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Burkholderia Cepacia Med (mast)
EUDAMEDClass A (EU MDR)
Ref PO0696A
by Oxoid Ltd
Identity
- Trade Name
- BURKHOLDERIA CEPACIA MED (MAST) EUDAMED
- Device Name
- BURKHOLDERIA CEPACIA MED (MAST) EUDAMED
- Model / Reference
- PO0696A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05032384023943 EUDAMED
- Basic UDI-DI
- 5032384BurkCepAgarP2FL EUDAMED
- EMDN Code
- W0104010405 NON-CHROMOGENIC MEDIA (PLATES) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
Burkholderia Cepacia Med (mast) by Oxoid 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 | 5032384BurkCepAgarP2FL | Class A | Active |
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Manufacturer
- Manufacturer
- Oxoid Ltd
- EUDAMED SRN
- GB-MF-000016914
- Authorised Representative
- Thermo Fisher Diagnostics B.V. NL-AR-000013157
Sources (1)
- EUDAMED 4550c346-e9e0-4153-ac01-12f10389667a 61 fields · synced Jul 18, 2026