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TREN

Last updated

23.09.2026 00:13

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Device

3539656

Actor

47778

Certificate

3398

Active filter:EMDN:W0201

1000+ device results listed.

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On Call

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IVD Class CIVDR 2017/746On the marketInstrumentKitMicrobial substancesNear-patient testingProfessional testingReagentSelf testing
Manufacturer
Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN
CN-MF-000006977
UDI-DI
06921756497781
Basic UDI-DI
6921756499990045XB
Reference
G115-11H-201
EMDN
W0201060102
EMDN description
BLOOD GLUCOSE METERS
First on market country
-
Safety summary (SSCP/SSP)
SSP-0068A/B · Rev. 1.1
Authorised representative
MedNet EC-REP GmbH
Last updated
06.08.2026 19:28
Manufacturer productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView details
On Call

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IVD Class CIVDR 2017/746On the marketInstrumentKitMicrobial substancesNear-patient testingProfessional testingReagentSelf testing
Manufacturer
Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN
CN-MF-000006977
UDI-DI
06921756497798
Basic UDI-DI
6921756499990045XB
Reference
G115-12H-201
EMDN
W0201060102
EMDN description
BLOOD GLUCOSE METERS
First on market country
-
Safety summary (SSCP/SSP)
SSP-0068A/B · Rev. 1.1
Authorised representative
MedNet EC-REP GmbH
Last updated
06.08.2026 19:28
Manufacturer productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView details
ACQUITY UPLC Sample Organizer IVD

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IVD Class AIVDR 2017/746On the marketDirect markingInstrument
Manufacturer
Waters Corporation
Manufacturer SRN
US-MF-000025801
UDI-DI
00816776020476
Basic UDI-DI
081677602MSTKPF0802BU
Reference
186015014IVD
EMDN
W0201050201
EMDN description
HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS
First on market country
-
Authorised representative
Emergo Europe B.V.
Last updated
05.08.2026 22:45
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
BIO-FLASH Narrow Tube Sample Adaptor

BIO-FLASH

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
Manufacturer
Biokit S.A.
Manufacturer SRN
ES-MF-000002406
UDI-DI
08436003070702
Basic UDI-DI
84269506397259T
Reference
3410-0872
EMDN
W0201020180
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country
Spain
Authorised representative
-
Last updated
05.08.2026 19:56
Manufacturer productsView details
BIO-FLASH High Capacity Rinse Accessory

BIO-FLASH

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
Manufacturer
Biokit S.A.
Manufacturer SRN
ES-MF-000002406
UDI-DI
08436003070696
Basic UDI-DI
84269506397259T
Reference
3410-0887
EMDN
W0201020180
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country
Spain
Authorised representative
-
Last updated
05.08.2026 19:29
Manufacturer productsView details
BIO-FLASH Sample Racks Adapters

BIO-FLASH

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
Manufacturer
Biokit S.A.
Manufacturer SRN
ES-MF-000002406
UDI-DI
08436003070689
Basic UDI-DI
84269506397259T
Reference
3410-0825
EMDN
W0201020180
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country
Spain
Authorised representative
-
Last updated
05.08.2026 18:49
Manufacturer productsView details
BIO-FLASH Sample Racks

BIO-FLASH

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
Manufacturer
Biokit S.A.
Manufacturer SRN
ES-MF-000002406
UDI-DI
08436003070672
Basic UDI-DI
84269506397259T
Reference
3410-0823
EMDN
W0201020180
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country
Spain
Authorised representative
-
Last updated
05.08.2026 16:42
Manufacturer productsView details
BIO-FLASH Cuvette Waste Bin

BIO-FLASH

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
Manufacturer
Biokit S.A.
Manufacturer SRN
ES-MF-000002406
UDI-DI
08436003070665
Basic UDI-DI
84269506397259T
Reference
3410-0824
EMDN
W0201020180
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country
Spain
Authorised representative
-
Last updated
05.08.2026 16:33
Manufacturer productsView details
Automated Multiplex Immunoassay System

P8

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Chengdu Illumaxbio Technology Co.,LTD
Manufacturer SRN
CN-MF-000026407
UDI-DI
06980222380071
Basic UDI-DI
697529264007N4
Reference
E203
EMDN
W0201020101
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country
France
Authorised representative
MedNet EC-REP GmbH
Last updated
05.08.2026 16:30
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Automated Multiplex Immunoassay System

P16s

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Chengdu Illumaxbio Technology Co.,LTD
Manufacturer SRN
CN-MF-000026407
UDI-DI
06980222380064
Basic UDI-DI
697529264006N2
Reference
E202
EMDN
W0201020101
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country
France
Authorised representative
MedNet EC-REP GmbH
Last updated
05.08.2026 16:30
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Automated Multiplex Immunoassay System

P16

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Chengdu Illumaxbio Technology Co.,LTD
Manufacturer SRN
CN-MF-000026407
UDI-DI
06980222380057
Basic UDI-DI
697529264005MY
Reference
E201
EMDN
W0201020101
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country
France
Authorised representative
MedNet EC-REP GmbH
Last updated
05.08.2026 16:30
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Automated CLEIA system

lumiflx16s

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Chengdu Illumaxbio Technology Co.,LTD
Manufacturer SRN
CN-MF-000026407
UDI-DI
06980222380040
Basic UDI-DI
697529264004MW
Reference
E104
EMDN
W0201020101
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country
France
Authorised representative
MedNet EC-REP GmbH
Last updated
05.08.2026 16:30
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Automated CLEIA system

lumilite8

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Chengdu Illumaxbio Technology Co.,LTD
Manufacturer SRN
CN-MF-000026407
UDI-DI
06980222380026
Basic UDI-DI
697529264002MS
Reference
E102
EMDN
W0201020101
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country
France
Authorised representative
MedNet EC-REP GmbH
Last updated
05.08.2026 16:30
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Automated CLEIA system

lumiflx16

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Chengdu Illumaxbio Technology Co.,LTD
Manufacturer SRN
CN-MF-000026407
UDI-DI
06980222380019
Basic UDI-DI
697529264001MQ
Reference
E101
EMDN
W0201020101
EMDN description
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country
France
Authorised representative
MedNet EC-REP GmbH
Last updated
05.08.2026 16:30
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06975668515002

Urine Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Jiangsu Jinzhun Biotech Co., Ltd.
Manufacturer SRN
CN-MF-000027592
UDI-DI
06975668515002
Basic UDI-DI
697566851URINEJZ500F9
Reference
W020101020102
EMDN
W020101020102
EMDN description
SEMI-AUTOMATED URINE ANALYSERS
First on market country
Türkiye
Authorised representative
MedNet EC-REP GmbH
Last updated
05.08.2026 16:29
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
LYSUN

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IVD Class ANot specifiedOn the marketSingle use
Manufacturer
Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN
CN-MF-000010254
UDI-DI
6971771202181
Basic UDI-DI
697177120GULP102T7
Reference
GULP-102
EMDN
W0201069092
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country
Spain
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA
Last updated
05.08.2026 16:24
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
URcheck™ NeoChem Analyzer

AC-H800

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN
CN-MF-000017965
UDI-DI
06950996046930
Basic UDI-DI
69509960AC-H800DE
Reference
AC-H800
EMDN
W0201010101
EMDN description
CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
05.08.2026 16:20
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details