← Back to catalogue
Sentosa SA vanA/vanB PCR Test
EUDAMEDClass IVD General (EU MDR)
Ref 300015, 300016
Identity
- Trade Name
- Sentosa SA vanA/vanB PCR Test EUDAMED
- Device Name
- Sentosa SA vanA/vanB PCR Test EUDAMED
- Model / Reference
- 300015, 300016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-888501395SSAvanABT3Q EUDAMED
- Basic UDI-DI
- B-888501395SSAvanABT3Q EUDAMED
- EMDN Code
- W0104080604 NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED VRE 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 vanA/vanB PCR Test 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-888501395SSAvanABT3Q | 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 (2)
- EUDAMED 9f0cf205-7b32-4d80-8e32-adf52deb3cd6 61 fields · synced Jul 9, 2026
- EUDAMED 9f0cf205-7b32-4d80-8e32-adf52deb3cd6-1 61 fields · synced Jun 10, 2026