Identity
- Trade Name
- Sentosa SX101 EUDAMEDFDA UDI
- Generic Name
- Nucleic acid sample preparation instrument IVD FDA UDI
- Device Name
- Sentosa SX101 EUDAMEDSentosa SX101 is an automated pipetting instrument designed for contamination-free, precise and correct measuring and transferring of liquids. FDA UDI
- Model / Reference
- 400089 EUDAMEDFDA UDI
- Description
- Sentosa SX101 is an automated pipetting instrument designed for contamination-free, precise and correct measuring and transferring of liquids. FDA UDI
Identifiers
- Catalog Number
- 400089 FDA UDI
- Primary DI / UDI-DI
- 08885013950007 EUDAMEDFDA UDI
- Basic UDI-DI
- 888501395SSX101TP EUDAMED
- Direct Marketing DI
- 08885013950007 EUDAMED
- FDA Product Code
- JQW FDA UDI
- EMDN Code
- W02060102 AUTOMATED SAMPLE TRANSPORT SYSTEMS EUDAMED
- GMDN Term
- Nucleic acid sample preparation instrument IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2750 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
No
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 SX101 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 | 888501395SSX101TP | 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 7b949cea-b5fd-4e8a-aa5b-b38e05ba2e28 61 fields · synced Aug 2, 2026
- FDA UDI a96a44f2-4f43-4390-931f-bc32784d9a5f 34 fields · synced May 30, 2026