Identity
- Trade Name
- OTEB 100mL EUDAMED
- Device Name
- Anaerobic Culture Media EUDAMED
- Model / Reference
- AS-6031 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810048902521 EUDAMED
- Basic UDI-DI
- 081004890ANAEROBEDT EUDAMED
- EMDN Code
- W0104010306 CULTURE MEDIA IN BOTTLES 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
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
OTEB 100mL by Anaerobe Systems — 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 | 081004890ANAEROBEDT | Class A | Active |
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Manufacturer
- Manufacturer
- Anaerobe Systems
- EUDAMED SRN
- US-MF-000040030
- Authorised Representative
- Casus Europe B.V. NL-AR-000037688
Sources (1)
- EUDAMED eb535461-51cc-49d9-a6fa-7a355b469525 61 fields · synced Jun 17, 2026