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ViroKey SX Virus Total Nucleic Acid (4x48)
EUDAMEDClass A (EU MDR)
Ref 300678Model 300678, 301089
Identity
- Trade Name
- ViroKey SX Virus Total Nucleic Acid (4x48) EUDAMED
- Device Name
- ViroKey Virus Total Nucleic Acid Kit EUDAMED
- Model / Reference
- 300678, 301089 EUDAMED300678 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08885013958218 EUDAMED
- Basic UDI-DI
- 888501395VKVTNA2S EUDAMED
- Direct Marketing DI
- 08885013958218 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
ViroKey SX Virus Total Nucleic Acid (4x48) by Vela Operations Singapore Pte. Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Nucleic acid extraction/isolation kit IVD.
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- 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 | 888501395VKVTNA2S | 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 48b0025b-c53e-4ffc-bce9-5221fbd50cc1 61 fields · synced Jul 10, 2026