Identity
- Trade Name
- Sentosa SA BKV PCR Test (4X48) EUDAMED
- Device Name
- Sentosa SA BKV PCR Test (4X48) EUDAMED
- Model / Reference
- 300636 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08885013953749 EUDAMED
- Basic UDI-DI
- B-08885013953749 EUDAMED
- EMDN Code
- W0105040522 BK VIRUS - 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 BKV PCR Test (4X48) 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-08885013953749 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vela Operations Singapore Pte. Ltd.
- EUDAMED SRN
- SG-MF-000025684
- Authorised Representative
- Vela Diagnostics Germany GmbH DE-AR-000016088
Sources (1)
- EUDAMED 6e40ae02-9686-4bc6-a03e-339f17fba1dc 61 fields · synced Oct 6, 2026