Identity
- Trade Name
- Sentosa ST Template Kit (8) EUDAMED
- Device Name
- Sentosa SQ301 Platform EUDAMED
- Model / Reference
- 690025 EUDAMED690006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08885013956207 EUDAMED
- Basic UDI-DI
- 888501395SSQ301P2E EUDAMED
- Direct Marketing DI
- 08885013956207 EUDAMED
- EMDN Code
- W02050185 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES 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
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Sentosa ST Template Kit (8) 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 | 888501395SSQ301P2E | 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 4008620c-9687-4cbb-9512-dcd89b703bef 61 fields · synced Jun 18, 2026