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Biocomma
EUDAMEDClass A (EU MDR)
Ref Type A (peripheral blood)5mlModel Type A(peripheral blood)
Identity
- Trade Name
- Biocomma EUDAMED
- Device Name
- Cell Culture Medium EUDAMED
- Model / Reference
- Type A(peripheral blood) EUDAMEDType A (peripheral blood)5ml EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974660730468 EUDAMED
- Basic UDI-DI
- 697466073AP15L4 EUDAMED
- Direct Marketing DI
- 06974660730468 EUDAMED
- EMDN Code
- W0104010203 TRANSPORT MEDIA EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
Yes
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Biocomma by Biocomma Limited — 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 | 697466073AP15L4 | Class A | Active |
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Manufacturer
- Manufacturer
- Biocomma Limited
- EUDAMED SRN
- CN-MF-000013631
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED c2aac6d7-b2bd-449c-831f-5f71861455f0 61 fields · synced Jun 19, 2026