← Back to catalogue
Carbohydrate Antigen 19-9（CA19-9）Assay Kit（Chemiluminescent Immunoassay）
EUDAMEDClass IVD General (EU MDR)
Ref 100 tests/kit
Identity
- Device Name
- Carbohydrate Antigen 19-9（CA19-9）Assay Kit（Chemiluminescent Immunoassay） EUDAMED
- Model / Reference
- 100 tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937287300353 EUDAMED
- Basic UDI-DI
- B-06937287300353 EUDAMED
- EMDN Code
- W0102030103 CANCER ANTIGEN 19-9 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Carbohydrate Antigen 19-9（CA19-9）Assay Kit（Chemiluminescent Immunoassay） by Shenzhen AmTech Bioengineering Ltd., Inc. — Class IVD General — IVDD — listed in…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06937287300353 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen AmTech Bioengineering Ltd., Inc.
- EUDAMED SRN
- CN-MF-000043067
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 09678242-4371-4b30-9736-2cdd5fd425bf 61 fields · synced Jun 18, 2026