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193 device results listed.

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HOKAPI™ SARS-CoV-2 IgM

100 TESTS

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390439999
Basic UDI-DI: B-06971390439999
Reference: 010220101
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 12:56

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ SARS-CoV-2 IgG

100 TESTS

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390439975
Basic UDI-DI: B-06971390439975
Reference: 010219101
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 12:56

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ CLEANING

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390435038
Basic UDI-DI: 69713904309088X
Reference: 010908301
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:55

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ CLEANING SOLUTION

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390435021
Basic UDI-DI: 69713904309048P
Reference: 010904301
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:55

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ SUBSTRATE SOLUTION 2

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390435014
Basic UDI-DI: 69713904309138Q
Reference: 010913301
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:55

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ SUBSTRATE SOLUTION 1

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390435007
Basic UDI-DI: 69713904309128N
Reference: 010912301
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:55

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ AE-180

AE-180

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390434994
Basic UDI-DI: 697139043AE18E9
Reference: AE18-MA00-0031
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 11:55

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ SAMPLE DILUENT 1

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716405509
Basic UDI-DI: 69713904309098Z
Reference: 0109092001
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:55

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ SAMPLE DILUENT

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716405486
Basic UDI-DI: 69713904309078V
Reference: 0109072001
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:55

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ TOTAL 25OH VITAMIN D

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716405332
Basic UDI-DI: 69713904311067S
Reference: 011106001
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:55

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ B·R·A·H·M·S PCT

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716405295
Basic UDI-DI: 69713904310047H
Reference: 011004001
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:55

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ IL-6

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716405271
Basic UDI-DI: 69713904310027D
Reference: 011002001
EMDN: W01030609
EMDN description: INTERLEUKIN 6 (IL-6)
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:55

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ FERRITIN

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

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716405257
Basic UDI-DI: 69713904309018H
Reference: 010901001
EMDN: W0102070102
EMDN description: FERRITIN
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:55

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ HS TROPONIN I

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716405219
Basic UDI-DI: 69713904307138E
Reference: 010713001
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:55

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ NT-PROBNP

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

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716405196
Basic UDI-DI: 69713904307068H
Reference: 010706001
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: 02.07.2026 11:55

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ CRP

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

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716405172
Basic UDI-DI: 69713904307048D
Reference: 010704001
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:55

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ CK MB

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

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716405158
Basic UDI-DI: 69713904307038B
Reference: 010703001
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:55

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ MYOGLOBIN

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

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716405134
Basic UDI-DI: 697139043070289
Reference: 010702001
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:55

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ BETA2-MG

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

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716405110
Basic UDI-DI: 69713904306068C
Reference: 010606001
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:54

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ C-PEPTIDE

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

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716405097
Basic UDI-DI: 697139043060284
Reference: 010602001
EMDN: W0102060101
EMDN description: C-PEPTIDE
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:54

Manufacturer products Authorised representative products Authorised representative actors View details