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Viral RNA Extraction Kit (for Auto-Extraction)
EUDAMEDClass A (EU MDR)
Ref ME-0092-96Model MVR10Ref ME-0091-240Model MVR09Ref ME-0091-60Ref ME-0092-384
Identity
- Trade Name
- Viral RNA Extraction Kit (for Auto-Extraction) EUDAMEDViral RNA Extraction Kit EUDAMED
- Device Name
- Viral RNA Extraction Kit (for Auto-Extraction) EUDAMEDViral RNA Extraction Kit EUDAMED
- Model / Reference
- MVR10 EUDAMEDME-0092-96 EUDAMEDMVR09 EUDAMEDME-0091-240 EUDAMEDME-0091-60 EUDAMEDME-0092-384 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971042228216 EUDAMED06971042228209 EUDAMED06971042228193 EUDAMED06971042228223 EUDAMED
- Basic UDI-DI
- 697104222010007EV EUDAMED697104222010008EX EUDAMED
- Direct Marketing DI
- 06971042228216 EUDAMED06971042228209 EUDAMED06971042228193 EUDAMED06971042228223 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
- France 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
Category: Nucleic acid extraction/isolation kit IVD
Viral RNA Extraction Kit (for Auto-Extraction) by Shanghai Zj Bio-Tech Co., 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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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 | 697104222010007EV | Class A | Active |
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Manufacturer
- Manufacturer
- Shanghai Zj Bio-Tech Co., Ltd
- EUDAMED SRN
- CN-MF-000017861
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (4)
- EUDAMED 794e8015-0443-4782-86e4-9c1e2d5d9a94 61 fields · synced Aug 3, 2026
- EUDAMED 8f95da8f-551d-4156-b025-214417db9ce1 61 fields · synced May 16, 2026
- EUDAMED d45bbde5-5fa4-428f-874d-743fd56d094c 61 fields · synced May 18, 2026
- EUDAMED 56bad668-28a1-4246-a715-8cd4105d918c 61 fields · synced May 19, 2026