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TREN

Last updated

01.08.2026 09:11

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Successful

Device

2989300

Actor

47520

Certificate

3174

Active filter:EMDN:W01021607

406 device results listed.

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Cardiac Troponin I Rapid Test

Cardiac Troponin I Rapid Test

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN
CN-MF-000010710
UDI-DI
06936983104616
Basic UDI-DI
6970277510000IXT
Reference
CTNI-N402-10
EMDN
W0102160703
EMDN description
TROPONIN I/T - RT & POC
First on market country
Ireland
Authorised representative
MedNet EC-REP GmbH
Last updated
31.07.2026 20:56
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-R225152H

50 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN
CN-MF-000011141
UDI-DI
D-R225152H
Basic UDI-DI
B-R225152H
Reference
R22515
EMDN
W0102160705
EMDN description
HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC
First on market country
Ireland
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
22.07.2026 15:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-R225142F

30 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN
CN-MF-000011141
UDI-DI
D-R225142F
Basic UDI-DI
B-R225142F
Reference
R22514
EMDN
W0102160705
EMDN description
HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC
First on market country
Ireland
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
22.07.2026 15:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-R225132D

200 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN
CN-MF-000011141
UDI-DI
D-R225132D
Basic UDI-DI
B-R225132D
Reference
R22513
EMDN
W0102160705
EMDN description
HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC
First on market country
Ireland
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
22.07.2026 15:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-R225122B

100 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN
CN-MF-000011141
UDI-DI
D-R225122B
Basic UDI-DI
B-R225122B
Reference
R22512
EMDN
W0102160705
EMDN description
HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC
First on market country
Ireland
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
22.07.2026 15:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-R2251129

50 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN
CN-MF-000011141
UDI-DI
D-R2251129
Basic UDI-DI
B-R2251129
Reference
R22511
EMDN
W0102160705
EMDN description
HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC
First on market country
Ireland
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
22.07.2026 15:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Cardiac Troponin I Rapid Test Cassette (Serum/Plasma/Whole Blood)

Cardiac Troponin I Rapid Test Cassette (Serum/Plasma/Whole Blood)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing
Manufacturer
Kalians Corporation
Manufacturer SRN
EG-MF-000050142
UDI-DI
62230182723422
Basic UDI-DI
B-62230182723422
Reference
D-789 001
EMDN
W0102160703
EMDN description
TROPONIN I/T - RT & POC
First on market country
Germany
Authorised representative
MDSS GmbH
Last updated
20.07.2026 04:47
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06935784460402

BF S15

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN
CN-MF-000014455
UDI-DI
06935784460402
Basic UDI-DI
B-06935784460402
Reference
BF-S151
EMDN
W0102160703
EMDN description
TROPONIN I/T - RT & POC
First on market country
Italy
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
19.07.2026 07:57
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06935784460204

BF S05

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN
CN-MF-000014455
UDI-DI
06935784460204
Basic UDI-DI
B-06935784460204
Reference
BF-S051
EMDN
W0102160706
EMDN description
MULTIPLE CARDIAC MARKERS - RT & POC
First on market country
Italy
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
19.07.2026 07:57
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06935784460105

BF S18

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN
CN-MF-000014455
UDI-DI
06935784460105
Basic UDI-DI
B-06935784460105
Reference
BF-S181
EMDN
W0102160704
EMDN description
BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country
Italy
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
19.07.2026 07:57
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
cTnI Quantitative Test Kit (Time-Resolved FIA)

FDTRO-402b-DR10, FDTRO-402b-DR10LH, FDTRO-402b-DR10HG, FDTRO-402b-DR, FDTRO-402b-DRLH, FDTRO-402b-DRHG

IVD Class CIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN
CN-MF-000017965
UDI-DI
06950996003889
Basic UDI-DI
69509960FDTRO-402b-DRDH
Reference
FDTRO-402b-DR10
EMDN
W0102160703
EMDN description
TROPONIN I/T - RT & POC
First on market country
Germany
Safety summary (SSCP/SSP)
CEDR-FDTRO-402b-11.1-OG · Rev. 4.0
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
18.07.2026 13:49
Manufacturer productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView details
NT-proBNP Quantitative Test Kit (Time-Resolved FIA)

FDBNP-402a-DR10, FDBNP-402a-DR, FDBNP-402a-DR10LH, FDBNP-402a-DRLH, FDBNP-402a-DR10HG, FDBNP-402a-DRHG

IVD Class CIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN
CN-MF-000017965
UDI-DI
06950996003827
Basic UDI-DI
69509960FDBNP-402a-DRQU
Reference
FDBNP-402a-DR10
EMDN
W0102160704
EMDN description
BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country
Germany
Safety summary (SSCP/SSP)
CEDR-FDBNP-402a-11.1-OG · Rev. 2.0
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
18.07.2026 13:49
Manufacturer productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView details
cTnI/CK-MB/Myo Quantitative Test Kit (Time-Resolved FIA)

FDCAR-T402a-DR10, FDCAR-T402a-DR10LH, FDCAR-T402a-DR10HG, FDCAR-T402a-DR, FDCAR-T402a-DRLH, FDCAR-T402a-DRHG

IVD Class CIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN
CN-MF-000017965
UDI-DI
06950996003865
Basic UDI-DI
69509960FDCAR-T402a-DRQ4
Reference
FDCAR-T402a-DR10
EMDN
W0102160706
EMDN description
MULTIPLE CARDIAC MARKERS - RT & POC
First on market country
Germany
Safety summary (SSCP/SSP)
CEDR-FDCAR-T402a-11-OG · Rev. 4.0
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
18.07.2026 13:49
Manufacturer productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView details
NT-proBNP Quantitative Test Kit (Time-Resolved FIA)

-

IVD Class CIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN
CN-MF-000017965
UDI-DI
06950996003834
Basic UDI-DI
69509960FDBNP-402a-DRQU
Reference
FDBNP-402a-DR
EMDN
W0102160704
EMDN description
BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country
-
Safety summary (SSCP/SSP)
CEDR-FDBNP-402a-11.1-OG · Rev. 2.0
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
18.07.2026 13:47
Manufacturer productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView details
cTnI/CK-MB/Myo Quantitative Test Kit (Time-Resolved FIA)

-

IVD Class CIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN
CN-MF-000017965
UDI-DI
06950996003872
Basic UDI-DI
69509960FDCAR-T402a-DRQ4
Reference
FDCAR-T402a-DR
EMDN
W0102160706
EMDN description
MULTIPLE CARDIAC MARKERS - RT & POC
First on market country
-
Safety summary (SSCP/SSP)
CEDR-FDCAR-T402a-11-OG · Rev. 4.0
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
18.07.2026 13:47
Manufacturer productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView details
cTnI Quantitative Test Kit (Time-Resolved FIA)

-

IVD Class CIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN
CN-MF-000017965
UDI-DI
06950996003896
Basic UDI-DI
69509960FDTRO-402b-DRDH
Reference
FDTRO-402b-DR
EMDN
W0102160703
EMDN description
TROPONIN I/T - RT & POC
First on market country
-
Safety summary (SSCP/SSP)
CEDR-FDTRO-402b-11.1-OG · Rev. 4.0
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
18.07.2026 13:47
Manufacturer productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView details
cTnI/CK-MB/Myo Quantitative Test Kit (Time-Resolved FIA)

-

IVD Class CIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN
CN-MF-000017965
UDI-DI
06950996037464
Basic UDI-DI
69509960FDCAR-T402a-DRQ4
Reference
FDCAR-T402a-DR10LH
EMDN
W0102160706
EMDN description
MULTIPLE CARDIAC MARKERS - RT & POC
First on market country
-
Safety summary (SSCP/SSP)
CEDR-FDCAR-T402a-11-OG · Rev. 4.0
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
18.07.2026 13:47
Manufacturer productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView details
NT-proBNP Quantitative Test Kit (Time-Resolved FIA)

-

IVD Class CIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN
CN-MF-000017965
UDI-DI
06950996040969
Basic UDI-DI
69509960FDBNP-402a-DRQU
Reference
FDBNP-402a-DRLH
EMDN
W0102160704
EMDN description
BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country
-
Safety summary (SSCP/SSP)
CEDR-FDBNP-402a-11.1-OG · Rev. 2.0
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
18.07.2026 13:47
Manufacturer productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView details
NT-proBNP Quantitative Test Kit (Time-Resolved FIA)

-

IVD Class CIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN
CN-MF-000017965
UDI-DI
06950996052214
Basic UDI-DI
69509960FDBNP-402a-DRQU
Reference
FDBNP-402a-DRHG
EMDN
W0102160704
EMDN description
BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country
-
Safety summary (SSCP/SSP)
CEDR-FDBNP-402a-11.1-OG · Rev. 2.0
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
18.07.2026 13:47
Manufacturer productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView details
cTnI/CK-MB/Myo Quantitative Test Kit (Time-Resolved FIA)

-

IVD Class CIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN
CN-MF-000017965
UDI-DI
06950996061698
Basic UDI-DI
69509960FDCAR-T402a-DRQ4
Reference
FDCAR-T402a-DRLH
EMDN
W0102160706
EMDN description
MULTIPLE CARDIAC MARKERS - RT & POC
First on market country
-
Safety summary (SSCP/SSP)
CEDR-FDCAR-T402a-11-OG · Rev. 4.0
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
18.07.2026 13:47
Manufacturer productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView details