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Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24)
EUDAMEDClass A (EU MDR)
Ref 300042
Identity
- Trade Name
- Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24) EUDAMED
- Device Name
- Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24) EUDAMED
- Model / Reference
- 300042 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08885013958034 EUDAMED
- Basic UDI-DI
- 888501395SSXVTNAv2WK EUDAMED
- Direct Marketing DI
- 08885013958034 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
Category: Nucleic acid extraction/isolation kit IVD
Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24) by Vela Operations Singapore Pte. Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Nucleic acid extraction/isolation kit IVD.
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- HPLC column — Immundiagnostik AG · Class A
- VIRCLIA® EXTRACTION SOLUTION — Vircell, S.L · Class A
- ViraSens Total Nucleic Acid Purification Kit — Vitrosens Biotechnology Inc. · Class A
- Nucleic Acid Extraction Kit — Bioteke Corporation (Wuxi) Co., Ltd. · Class A
- MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A
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 | 888501395SSXVTNAv2WK | 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 1fe280f7-8b87-4fbf-94f6-8d4dd17f2249 61 fields · synced May 22, 2026