Identity
- Trade Name
- BloodPrime EUDAMED
- Device Name
- BloodPrime EUDAMED
- Model / Reference
- M443106 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16972698604291 EUDAMED
- Basic UDI-DI
- 697269860RDT006TA EUDAMED
- Direct Marketing DI
- 16972698604291 EUDAMED
- EMDN Code
- W0104010805 BUFFERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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
New Device
No
EUDAMED
BloodPrime by Hangzhou Genesis Biodetection and Biocontrol 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 | 697269860RDT006TA | Class A | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000013495
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED a17d41fe-a627-48fb-85ca-9c1eeea92c9e 61 fields · synced Jun 19, 2026