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Sentosa SQ Reporter Software
EUDAMEDClass IVD General (EU MDR)
Ref 480169, 480183, 480185, 480187, 480204Model 480169, 480183, 480185, 480187, 480198, 480204
Identity
- Trade Name
- Sentosa SQ Reporter Software EUDAMED
- Device Name
- Sentosa SQ Reporter Software EUDAMED
- Model / Reference
- 480169, 480183, 480185, 480187, 480198, 480204 EUDAMED480169, 480183, 480185, 480187, 480204 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-888501395SSQRep78 EUDAMED
- Basic UDI-DI
- B-888501395SSQRep78 EUDAMED
- EMDN Code
- W02050192 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE 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
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Sentosa SQ Reporter Software 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-888501395SSQRep78 | 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 18ab25a1-8cbf-4762-903a-cf629897b5c5 61 fields · synced Oct 6, 2026
- EUDAMED 18ab25a1-8cbf-4762-903a-cf629897b5c5-1 61 fields · synced Jun 10, 2026