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Great Basin Stool Bacterial Pathogens Panel
EUDAMEDClass IVD General (EU MDR)
Ref 300780
Identity
- Trade Name
- Great Basin Stool Bacterial Pathogens Panel EUDAMED
- Device Name
- Great Basin Stool Bacterial Pathogens Panel EUDAMED
- Model / Reference
- 300780 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-888501395GBStoolJB EUDAMED
- Basic UDI-DI
- B-888501395GBStoolJB EUDAMED
- EMDN Code
- W0105011699 BACTERIOLOGY - NA REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Great Basin Stool Bacterial Pathogens Panel by Vela Operations Singapore Pte. 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-888501395GBStoolJB | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Vela Operations Singapore Pte. Ltd.
- EUDAMED SRN
- SG-MF-000025684
- Authorised Representative
- Vela Diagnostics Germany GmbH DE-AR-000016088
Sources (1)
- EUDAMED 792a584b-c046-4c02-bad5-1be40b54b9ed 61 fields · synced Jun 18, 2026