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ViraSens Viral DNA Purification Kit
EUDAMEDClass A (EU MDR)
Ref VIRA06Model VIRA06P50
Identity
- Trade Name
- ViraSens Viral DNA Purification Kit EUDAMED
- Device Name
- Viral DNA Purification Kit EUDAMED
- Model / Reference
- VIRA06P50 EUDAMEDVIRA06 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684595031094 EUDAMED
- Basic UDI-DI
- 868459503VIRA06P50W7 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
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
ViraSens Viral DNA Purification Kit by Vitrosens Biotechnology Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 868459503VIRA06P50W7 | Class A | Active |
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Manufacturer
- Manufacturer
- Vitrosens Biotechnology Inc.
- EUDAMED SRN
- TR-MF-000026452
Sources (1)
- EUDAMED 820c0156-9258-4eb4-ad52-426fb2b1c146 61 fields · synced Jun 19, 2026