Identity
- Trade Name
- Sentosa ST401i EUDAMEDFDA UDI
- Generic Name
- Clinical laboratory information system FDA UDI
- Device Name
- Sentosa SQ301 Platform EUDAMEDSentosa ST401i is used for emulsion PCR and forms part of SQ301 Platform. FDA UDI
- Model / Reference
- 690025 EUDAMED400124 EUDAMEDFDA UDI
- Description
- Sentosa ST401i is used for emulsion PCR and forms part of SQ301 Platform. FDA UDI
Identifiers
- Catalog Number
- 400124 FDA UDI
- Primary DI / UDI-DI
- 08885013950069 EUDAMEDFDA UDI
- Basic UDI-DI
- 888501395SSQ301P2E EUDAMED
- Direct Marketing DI
- 08885013950069 EUDAMED
- FDA Product Code
- PFF FDA UDI
- EMDN Code
- W02050199 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER EUDAMED
- GMDN Term
- Clinical laboratory information system FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.2265 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Sentosa ST401i by Vela Operations Singapore Pte. Ltd. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 888501395SSQ301P2E | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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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 8dd26970-77f6-4376-8276-7fd9c24a994f 61 fields · synced Jun 19, 2026
- FDA UDI 2bcfb494-dfbb-4ad6-b85b-8073062457f4 34 fields · synced May 30, 2026