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Automatic Blood Grouping Analyzer
EUDAMEDClass A (EU MDR)
Ref SA20-MA00-0008Model SA-120
Identity
- Trade Name
- Automatic Blood Grouping Analyzer EUDAMED
- Device Name
- Automatic Blood Grouping Analyzer EUDAMED
- Model / Reference
- SA-120 EUDAMEDSA20-MA00-0008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939716400283 EUDAMED
- Basic UDI-DI
- 69397164SA20VT EUDAMED
- Direct Marketing DI
- 06939716400283 EUDAMED
- EMDN Code
- W0202030102 AUTOMATED BLOOD GROUPING ANALYSERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Automatic Blood Grouping Analyzer by Suzhou Hokapi Biomedical Engineering Co., Ltd.. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69397164SA20VT | Class A | Active |
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Manufacturer
- Manufacturer
- Suzhou Hokapi Biomedical Engineering Co., Ltd..
- EUDAMED SRN
- CN-MF-000013723
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED f6785390-88a0-4791-af62-4e79c471baf7 61 fields · synced Jun 17, 2026