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Viral DNA/RNA Isolation Kit (for Auto-Extraction)
EUDAMEDClass A (EU MDR)
Ref ME-0096-500Model MVR18Ref ME-0096-2000Ref ME-0096-10000
Identity
- Trade Name
- Viral DNA/RNA Isolation Kit (for Auto-Extraction) EUDAMED
- Device Name
- Viral DNA/RNA Isolation Kit (for Auto-Extraction) EUDAMED
- Model / Reference
- MVR18 EUDAMEDME-0096-500 EUDAMEDME-0096-2000 EUDAMEDME-0096-10000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971042228261 EUDAMED06971042228278 EUDAMED06971042228285 EUDAMED
- Basic UDI-DI
- 697104222010012EN EUDAMED
- Direct Marketing DI
- 06971042228261 EUDAMED06971042228278 EUDAMED06971042228285 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 DNA/RNA Isolation 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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- 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 | 697104222010012EN | 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 (3)
- EUDAMED 65015c91-8159-4a53-9ee9-869d64d80124 61 fields · synced Jul 14, 2026
- EUDAMED dbe59233-c814-4cfb-b8c0-9b413d75b004 61 fields · synced May 17, 2026
- EUDAMED 21b46033-b280-4f72-b98c-fde1ecfb9d90 61 fields · synced May 19, 2026