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EUDAMED Device Search

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TREN

Last updated

23.09.2026 17:50

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Device

3578239

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Active filter:EMDN:W01020603

603 device results listed.

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04560189211414

ST AIA-PACK Intact PTH SAMPLE DILUTING SOLUTION

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent
Manufacturer
Tosoh Corporation
Manufacturer SRN
JP-MF-000024143
UDI-DI
04560189211414
Basic UDI-DI
B-04560189211414
Reference
0025513
EMDN
W0102060312
EMDN description
PARATHYROID HORMONE INTACT
First on market country
Belgium
Authorised representative
Tosoh Europe N.V.
Last updated
02.08.2026 10:42
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
AFIAS Vitamin D Neo

AFIAS Vitamin D Neo

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Boditech Med Inc.
Manufacturer SRN
KR-MF-000011028
UDI-DI
08806133041314
Basic UDI-DI
880613300598D7
Reference
SMFP-108
EMDN
W0102060309
EMDN description
25-HYDROXYVITAMIN D
First on market country
Cyprus
Authorised representative
Obelis s.a.
Last updated
01.08.2026 00:00
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
N-MID Osteocalcin (eCLIA)

50T，2×50T，100T，2×100T

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent
Manufacturer
Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN
CN-MF-000005654
UDI-DI
06975984063935
Basic UDI-DI
69703416803205102J4
Reference
0320510501
EMDN
W0102060311
EMDN description
OSTEOCALCINE
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
31.07.2026 21:14
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
25-hydroxy-vitamin D test (Up-converting Phosphor Technology)

Please see the IFU

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent
Manufacturer
Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN
CN-MF-000015566
UDI-DI
06936700406672
Basic UDI-DI
697029753307LF
Reference
HGUPT02
EMDN
W0102060309
EMDN description
25-HYDROXYVITAMIN D
First on market country
Germany
Authorised representative
MedNet EC-REP GmbH
Last updated
31.07.2026 21:09
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
25-hydroxy-vitamin D test (Chemiluminescence Immunoassay)

Please see the IFU

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent
Manufacturer
Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN
CN-MF-000015566
UDI-DI
06936700403169
Basic UDI-DI
697029753056LD
Reference
HGCL11
EMDN
W0102060309
EMDN description
25-HYDROXYVITAMIN D
First on market country
Germany
Authorised representative
MedNet EC-REP GmbH
Last updated
31.07.2026 21:07
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
25-OH Vitamin D CLIA Microparticles

AutoLumo analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent
Manufacturer
Autobio Diagnostics Co., Ltd.
Manufacturer SRN
CN-MF-000003348
UDI-DI
06942359542364
Basic UDI-DI
697015090000075HF
Reference
CMS0403
EMDN
W0102060309
EMDN description
25-HYDROXYVITAMIN D
First on market country
Italy
Authorised representative
QbD RepS BV
Last updated
31.07.2026 20:49
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
25-OH-Vitamin D Total (CLIA)

105-045515-00、105-045516-00

IVD Class BIVDR 2017/746On the marketDirect markingProfessional testingReagent
Manufacturer
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN
CN-MF-000014156
UDI-DI
06903053074063
Basic UDI-DI
69449040AB74000485Y
Reference
105-045516-00
EMDN
W0102060309
EMDN description
25-HYDROXYVITAMIN D
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
31.07.2026 19:51
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Total-P1NP (CLIA)

105-043537-00、105-043538-00、105-045132-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent
Manufacturer
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN
CN-MF-000014156
UDI-DI
06903053069908
Basic UDI-DI
69449040AB74000615Q
Reference
105-043537-00
EMDN
W0102060317
EMDN description
PROCOLLAGEN TYPE I N TERMINAL PROPEPTIDE
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
31.07.2026 19:51
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
iFlash-25-OH Vitamin D Ⅱ

iFlash-25-OH Vitamin D Ⅱ

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent
Manufacturer
SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN
CN-MF-000001137
UDI-DI
06925912724285
Basic UDI-DI
692591270278HY
Reference
C86326
EMDN
W0102060309
EMDN description
25-HYDROXYVITAMIN D
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
31.07.2026 18:36
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
iFlash-Calcitonin

iFlash-Calcitonin

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN
CN-MF-000001137
UDI-DI
06925912720492
Basic UDI-DI
692591270275HS
Reference
C86291
EMDN
W0102060301
EMDN description
CALCITONIN
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
31.07.2026 18:36
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
iFlash-Osteocalcin

iFlash-Osteocalcin

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN
CN-MF-000001137
UDI-DI
06925912720461
Basic UDI-DI
692591270277HW
Reference
C86289
EMDN
W0102060311
EMDN description
OSTEOCALCINE
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
31.07.2026 18:36
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
iFlash-PTH

iFlash-PTH

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN
CN-MF-000001137
UDI-DI
06925912718581
Basic UDI-DI
692591270021GR
Reference
C86038
EMDN
W0102060312
EMDN description
PARATHYROID HORMONE INTACT
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
31.07.2026 18:31
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
iFlash-25-OH Vitamin D

iFlash-25-OH Vitamin D

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent
Manufacturer
SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN
CN-MF-000001137
UDI-DI
06925912715412
Basic UDI-DI
692591270020GP
Reference
C86023-L
EMDN
W0102060309
EMDN description
25-HYDROXYVITAMIN D
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
31.07.2026 18:29
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
total sRANKL ELISA

total sRANKL ELISA

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Immundiagnostik AG
Manufacturer SRN
DE-MF-000020905
UDI-DI
04050598110168
Basic UDI-DI
B-04050598110168
Reference
K 1016
EMDN
W0102060399
EMDN description
BONE METABOLISM TESTS - OTHER
First on market country
Germany
Authorised representative
-
Last updated
31.07.2026 15:25
Manufacturer productsView details
1,25-(OH)2-Vitamin D ELISA

1,25-(OH)2-Vitamin D ELISA

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Immundiagnostik AG
Manufacturer SRN
DE-MF-000020905
UDI-DI
04050598121126
Basic UDI-DI
B-04050598121126
Reference
K 2112
EMDN
W0102060308
EMDN description
1.25-DIHYDROXYVITAMIN D
First on market country
Germany
Authorised representative
-
Last updated
31.07.2026 15:25
Manufacturer productsView details