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193 device results listed.

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HOKAPI™ PG I

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

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404656
Basic UDI-DI: 69713904301157L
Reference: 010115001
EMDN: W0102069006
EMDN description: PEPSINOGEN
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™ HE4

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

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404632
Basic UDI-DI: 69713904301147J
Reference: 010114001
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
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™ SCC

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

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404618
Basic UDI-DI: 69713904301137G
Reference: 010113001
EMDN: W0102030116
EMDN description: SQUAMOUS CELL CARCINOMA ANTIGEN
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™ NSE

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404595
Basic UDI-DI: 69713904301127E
Reference: 010112001
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
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™ CA 72-4

HOKAPI™ CA72-4

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

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404571
Basic UDI-DI: 69713904301117C
Reference: 010111001
EMDN: W0102030105
EMDN description: CANCER ANTIGEN 72-4
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™ CYFRA 21-1

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

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404557
Basic UDI-DI: 69713904301107A
Reference: 010110001
EMDN: W0102030111
EMDN description: CYFRA 21-1
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™ CA 242

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

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404533
Basic UDI-DI: 69713904301097R
Reference: 010109001
EMDN: W0102030108
EMDN description: CANCER ANTIGEN 242
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™ CA 50

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

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404519
Basic UDI-DI: 69713904301087P
Reference: 010108001
EMDN: W0102030104
EMDN description: CANCER ANTIGEN 50
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™ CA 15-3

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

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404496
Basic UDI-DI: 69713904301077M
Reference: 010107001
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
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™ CA 19-9

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

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404472
Basic UDI-DI: 69713904301067K
Reference: 010106001
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
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™ CA 125

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

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404458
Basic UDI-DI: 69713904301057H
Reference: 010105001
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
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™ FPSA

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

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404434
Basic UDI-DI: 69713904301047F
Reference: 010104001
EMDN: W0102030114
EMDN description: FREE PROSTATIC SPECIFIC ANTIGEN
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™ PSA

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

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404410
Basic UDI-DI: 69713904301037D
Reference: 010103001
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
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™ AFP

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

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404397
Basic UDI-DI: 69713904301027B
Reference: 010102001
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
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™ CEA

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

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404373
Basic UDI-DI: 697139043010179
Reference: 010101001
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
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™ CUVETTE

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404359
Basic UDI-DI: 697139043AE1800126N
Reference: AE20-FL00-0006
EMDN: W0503010203
EMDN description: SAMPLES ANALYSES, PLASTIC CUVETTES
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™ FOLATE

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716405462
Basic UDI-DI: 693971640905ME
Reference: 010905001
EMDN: W0102070103
EMDN description: FOLATE
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™ VITAMIN B12

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716405448
Basic UDI-DI: 693971640902M8
Reference: 010902001
EMDN: W0102070204
EMDN description: VITAMIN B12
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™ GASTRIN-17

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716405400
Basic UDI-DI: 693971640124LA
Reference: 010124401
EMDN: W0102069001
EMDN description: GASTRIN
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™ 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