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Sentosa SA HHV6 Quantitative PCR Test
EUDAMEDClass IVD General (EU MDR)
Ref 300157, 300184, 300180, 300673Model 300157, 300184, 300673, 300180
Identity
- Trade Name
- Sentosa SA HHV6 Quantitative PCR Test EUDAMED
- Device Name
- Sentosa SA HHV6 Quantitative PCR Test EUDAMED
- Model / Reference
- 300157, 300184, 300673, 300180 EUDAMED300157, 300184, 300180, 300673 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-888501395SSAHHV6QTT4A EUDAMED
- Basic UDI-DI
- B-888501395SSAHHV6QTT4A EUDAMED
- EMDN Code
- W0105040524 HHV-6,7,8 - 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 HHV6 Quantitative 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-888501395SSAHHV6QTT4A | 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 (2)
- EUDAMED 7788a9a5-d511-48a2-a99e-41713edb3bcd 61 fields · synced Jun 20, 2026
- EUDAMED 7788a9a5-d511-48a2-a99e-41713edb3bcd-1 61 fields · synced Jun 10, 2026