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Deben Escherichia coli Antisera
EUDAMEDClass IVD General (EU MDR)
Ref 296009Model O86a
Identity
- Device Name
- Deben Escherichia coli Antisera EUDAMED
- Model / Reference
- O86a EUDAMED296009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05061053151045 EUDAMED
- Basic UDI-DI
- B-05061053151045 EUDAMED
- EMDN Code
- W01029001 ANTISERA (MONOVALENT AND POLYVALENT) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Deben Escherichia coli Antisera by Deben Diagnostics Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-05061053151045 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Deben Diagnostics Ltd
- EUDAMED SRN
- GB-MF-000023695
- Authorised Representative
- EU-UK Authorised Representative Ltd XI-AR-000010192
Sources (1)
- EUDAMED da0978b8-f48b-41ac-80ef-47e1747a664c 61 fields · synced Jun 18, 2026