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Viral RNA Extraction Kit (Preloaded for Auto-Extraction)
EUDAMEDClass A (EU MDR)
Ref ME-0093-240Model MVR15
Identity
- Trade Name
- Viral RNA Extraction Kit (Preloaded for Auto-Extraction) EUDAMED
- Device Name
- Viral RNA Extraction Kit (Preloaded for Auto-Extraction) EUDAMED
- Model / Reference
- MVR15 EUDAMEDME-0093-240 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971042228254 EUDAMED
- Basic UDI-DI
- 697104222010010EJ EUDAMED
- Direct Marketing DI
- 06971042228254 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 (Preloaded for Auto-Extraction) by Shanghai Zj Bio-Tech Co., 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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- 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 | 697104222010010EJ | 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 (1)
- EUDAMED ead169f1-a1cd-4014-a7cf-ddc78a1e697b 61 fields · synced Jun 18, 2026