Identity
- Device Name
- Professional testing EUDAMED
- Model / Reference
- B01101M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975765870004 EUDAMED
- Basic UDI-DI
- 697576587YLDNAYBBCG1CK7 EUDAMED
- EMDN Code
- W050101010201 BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Estonia EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Professional testing by Anhui Weizhen Bioengineering Technology 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 | 697576587YLDNAYBBCG1CK7 | Class A | Active |
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Manufacturer
- Manufacturer
- Anhui Weizhen Bioengineering Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000036080
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED c7d342ab-6505-4487-ae9b-8d2fbbcd5239 61 fields · synced Jul 19, 2026