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Biocomma
EUDAMEDClass A (EU MDR)
Ref Type A (no preservation medium)Model Type A (contain preservation medium)
Identity
- Trade Name
- Biocomma EUDAMED
- Device Name
- Saliva Collectors EUDAMED
- Model / Reference
- Type A (contain preservation medium) EUDAMEDType A (no preservation medium) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16974660730205 EUDAMED
- Basic UDI-DI
- 697466073P07SB EUDAMED
- Direct Marketing DI
- 16974660730205 EUDAMED
- EMDN Code
- W05020104 SAMPLES TRANSPORT, VASES 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
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
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 | 697466073P07SB | 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 66c7d14d-3fb6-4bfd-bf23-43625fa216ab 61 fields · synced Jun 19, 2026