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193 device results listed.

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HOKAPI™ PIVKA-II

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716405363
Basic UDI-DI: 693971640125LC
Reference: 010125401
EMDN: W0102039017
EMDN description: PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II)
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:23

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ AE-200

AE-200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716402430
Basic UDI-DI: 69397164AE200LV
Reference: AE20-MA00-0002
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:23

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ AMH

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716401808
Basic UDI-DI: 693971640412LJ
Reference: 010412401
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:23

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ D-DIMER

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716400153
Basic UDI-DI: 693971640714M5
Reference: 010714101
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:23

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ PTH

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716401792
Basic UDI-DI: 693971641102L7
Reference: 011102101
EMDN: W0102060312
EMDN description: PARATHYROID HORMONE INTACT
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:23

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Blood Grouping Analyzer

SA-120

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716400283
Basic UDI-DI: 69397164SA20VT
Reference: SA20-MA00-0008
EMDN: W0202030102
EMDN description: AUTOMATED BLOOD GROUPING ANALYSERS
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:23

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ IL-6

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390439982
Basic UDI-DI: 69713904310027D
Reference: 011002101
EMDN: W01030609
EMDN description: INTERLEUKIN 6 (IL-6)
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 12:02

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ CRP

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390439944
Basic UDI-DI: 69713904307048D
Reference: 010704101
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 12:02

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ NT-PROBNP

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390439937
Basic UDI-DI: 69713904307068H
Reference: 010706101
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 12:02

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ CK MB

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390439920
Basic UDI-DI: 69713904307038B
Reference: 010703101
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 12:02

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ MYOGLOBIN

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390439913
Basic UDI-DI: 697139043070289
Reference: 010702101
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 12:02

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ HS TROPONIN I

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390439906
Basic UDI-DI: 69713904307138E
Reference: 010713101
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 12:02

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ C-PEPTIDE

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390439883
Basic UDI-DI: 697139043060284
Reference: 010602101
EMDN: W0102060101
EMDN description: C-PEPTIDE
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 12:02

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ INSULIN

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390439876
Basic UDI-DI: 697139043060182
Reference: 010601101
EMDN: W0102060103
EMDN description: INSULIN
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 12:02

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ BETA-HCG

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390439869
Basic UDI-DI: 697139043040988
Reference: 010409101
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 12:02

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ BETA-HCG

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390439852
Basic UDI-DI: 697139043040988
Reference: 010409401
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 12:02

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ HER-2/NEU

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390439746
Basic UDI-DI: 69713904301237K
Reference: 010123101
EMDN: W0102030301
EMDN description: HER-2/NEU
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 12:02

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ PROGRP

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390439739
Basic UDI-DI: 69713904301227H
Reference: 010122101
EMDN: W0102030121
EMDN description: PRO-GASTRIN-RELEASING PEPTIDE
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 12:02

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ PG II

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390439722
Basic UDI-DI: 69713904301167N
Reference: 010116101
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 12:02

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ PG I

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390439715
Basic UDI-DI: 69713904301157L
Reference: 010115101
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 12:02

Manufacturer products Authorised representative products Authorised representative actors View details