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Group B Strep Selective Enrichment Broth
EUDAMEDClass A (EU MDR)
Ref BO1338E
by Oxoid Ltd
Identity
- Trade Name
- GROUP B STREP SELECTIVE ENRICHMENT BROTH EUDAMED
- Device Name
- GROUP B STREP SELECTIVE ENRICHMENT BROTH EUDAMED
- Model / Reference
- BO1338E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05032384511921 EUDAMED
- Basic UDI-DI
- 5032384GBSEnrichBrothEJ 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
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
Group B Strep Selective Enrichment Broth 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 | 5032384GBSEnrichBrothEJ | 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 5ac696e0-f6f2-48b4-a3cb-f2b5297db87f 61 fields · synced Jun 18, 2026