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Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24)
EUDAMEDClass A (EU MDR)
Ref 300154
Identity
- Trade Name
- Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24) EUDAMED
- Device Name
- Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24) EUDAMED
- Model / Reference
- 300154 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08885013958072 EUDAMED
- Basic UDI-DI
- 888501395SSXVTNAPlus7G EUDAMED
- Direct Marketing DI
- 08885013958072 EUDAMED
- EMDN Code
- W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED
Classification
- Device Class
- Class A 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
New Device
No
EUDAMED
Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24) by Vela Operations Singapore Pte. Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 888501395SSXVTNAPlus7G | Class A | 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 eb1f7203-dced-4e6f-9e4e-1ad563770e04 61 fields · synced Jun 19, 2026