Identity
- Trade Name
- Sentosa SA Strep A PCR Test (4x8) EUDAMED
- Device Name
- Sentosa SA Strep A PCR Test (4x8) EUDAMED
- Model / Reference
- 300032 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08885013953091 EUDAMED
- Basic UDI-DI
- B-08885013953091 EUDAMED
- EMDN Code
- W0105011103 STREP. A DETECTION BY NA REAGENTS 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
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Sentosa SA Strep A PCR Test (4x8) 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-08885013953091 | 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 3e12dfd2-4e3c-4be5-a346-c38063df8563 61 fields · synced Jun 19, 2026