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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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23.09.2026 08:13

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06941967231028

IVD generalNot specifiedOn the market

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967231028
Basic UDI-DI: B-06941967231028
Reference: 0601501
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 25.06.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ PIVKA-II

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716405394
Basic UDI-DI: 693971640125LC
Reference: 010125601
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: 25.06.2026 02:07

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ PIVKA-II

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716405387
Basic UDI-DI: 693971640125LC
Reference: 010125001
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: 25.06.2026 02:07

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ PIVKA-II

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716405370
Basic UDI-DI: 693971640125LC
Reference: 010125101
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: 25.06.2026 02:07

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ BETA2-MG

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716405127
Basic UDI-DI: 69713904306068C
Reference: 010606601
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 25.06.2026 02:07

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ NSE

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404601
Basic UDI-DI: 69713904301127E
Reference: 010112601
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 25.06.2026 02:06

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ AFP

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404403
Basic UDI-DI: 69713904301027B
Reference: 010102601
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 25.06.2026 02:05

Manufacturer products Authorised representative products Authorised representative actors View details

06937287300643

IVD generalNot specifiedOn the market

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN: CN-MF-000043067
UDI-DI: 06937287300643
Basic UDI-DI: B-06937287300643
Reference: 100 tests/kit
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

06937287300636

IVD generalNot specifiedOn the market

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN: CN-MF-000043067
UDI-DI: 06937287300636
Basic UDI-DI: B-06937287300636
Reference: R1: 2×60 mL
EMDN: W0102039018
EMDN description: ALPHA-FUCOSIDASE
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

06937287300612

IVD generalNot specifiedOn the market

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN: CN-MF-000043067
UDI-DI: 06937287300612
Basic UDI-DI: B-06937287300612
Reference: 100 tests/kit
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

06937287300476

IVD generalNot specifiedOn the market

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN: CN-MF-000043067
UDI-DI: 06937287300476
Basic UDI-DI: B-06937287300476
Reference: R1: 2×40 mL, R2: 1×20 mL
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

Matrix Metalloproteinase-3 Kit (Latex-Enhanced Immunoturbidimetric Method)

IVD generalNot specifiedOn the market

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595752182
Basic UDI-DI: B-06936595752182
Reference: MJ494Y
EMDN: W0102039010
EMDN description: MATRIX-METALLOPROTEINASES
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 18:58

Manufacturer products Authorised representative products Authorised representative actors View details

α-L-Fucosidase Kit (Kinetic Method)

IVD generalNot specifiedOn the market

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595751826
Basic UDI-DI: B-06936595751826
Reference: MJ013Y
EMDN: W0102039018
EMDN description: ALPHA-FUCOSIDASE
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

Protein Induced By Vitamin K Absence or Antagonist-II Kit (CLIA)

IVD generalNot specifiedOn the market

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595751406
Basic UDI-DI: B-06936595751406
Reference: FG1219Y
EMDN: W0102039017
EMDN description: PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II)
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

S100 Protein Kit (CLIA)

IVD generalNot specifiedOn the market

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595751376
Basic UDI-DI: B-06936595751376
Reference: FG1216Y
EMDN: W0102039012
EMDN description: PROTEIN S-100 B
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

Neuron-Specific Enolase Kit (CLIA)

IVD generalNot specifiedOn the market

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595751352
Basic UDI-DI: B-06936595751352
Reference: FG1213Y
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

Alpha-Fetoprotein Kit (CLIA)

IVD generalNot specifiedOn the market

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595751246
Basic UDI-DI: B-06936595751246
Reference: FG1200Y
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

β2-Microglobin Kit (Latex-Enhanced Immunoturbidimetric Method)

IVD generalNot specifiedOn the market

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595750287
Basic UDI-DI: B-06936595750287
Reference: MJ410Y
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 18:54

Manufacturer products Authorised representative products Authorised representative actors View details

α-Fetoprotein Kit (Latex-Enhanced Immunoturbidimetric Method)

IVD generalNot specifiedOn the market

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595750249
Basic UDI-DI: B-06936595750249
Reference: MJ406Y
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 18:53

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid FOB Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: InTec PRODUCTS, INC.
Manufacturer SRN: CN-MF-000023625
UDI-DI: 06936155807161
Basic UDI-DI: B-06936155807161
Reference: ITP13001-TC20
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 15:14

Manufacturer products Authorised representative products Authorised representative actors View details