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Viral Transport Medium
EUDAMEDClass A (EU MDR)
Ref PR-0026-100Model RVR09Ref PR-0027-100Ref PR-0025-100
Identity
- Trade Name
- Viral Transport Medium EUDAMED
- Device Name
- Viral Transport Medium EUDAMED
- Model / Reference
- RVR09 EUDAMEDPR-0026-100 EUDAMEDPR-0027-100 EUDAMEDPR-0025-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971042228094 EUDAMED06971042228100 EUDAMED06971042228087 EUDAMED
- Basic UDI-DI
- 697104222010009EZ EUDAMED
- Direct Marketing DI
- 06971042228094 EUDAMED06971042228100 EUDAMED06971042228087 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 Transport Medium 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.
- Whole Blood DNA Extraction Kit (Magnetic Bead Method) — JIANGSU BIOPERFECTUS TECHNOLOGIES CO., LTD. · Class A
- abGenix™ Viral DNA and RNA Extraction Kit II (Plate) — AITbiotech Pte Ltd · Class A
- Nucleic Acid Extraction Kit — Shandong Bohong Gene Technology Co., Ltd. · Class A
- HPLC column — Immundiagnostik AG · Class A
- VIRCLIA® EXTRACTION SOLUTION — Vircell, S.L · Class A
- ViraSens Total Nucleic Acid Purification Kit — Vitrosens Biotechnology Inc. · Class A
- Nucleic Acid Extraction Kit — Bioteke Corporation (Wuxi) Co., Ltd. · Class A
- 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 | 697104222010009EZ | 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 de40c8dc-b21e-42a5-8bc0-fc5c515f3c69 61 fields · synced Jul 30, 2026
- EUDAMED 5b509923-049a-4a20-aa51-ae7d4bd9b429 61 fields · synced May 18, 2026
- EUDAMED c6434d20-f4cc-433b-95cc-1d0e5a4e82a5 61 fields · synced May 18, 2026