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ViraSens Viral RNA Purification Kit
EUDAMEDClass A (EU MDR)
Ref VIRA03Model VIRA03P100Model VIRA03P50
Identity
- Trade Name
- ViraSens Viral RNA Purification Kit EUDAMED
- Device Name
- Viral RNA Purification Kit EUDAMED
- Model / Reference
- VIRA03P100 EUDAMEDVIRA03 EUDAMEDVIRA03P50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683548253569 EUDAMED08684595031070 EUDAMED
- Basic UDI-DI
- 868354825VIRA03P100ES EUDAMED868459503VIRA03P50VJ 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
Category: Nucleic acid extraction/isolation kit IVD
ViraSens Viral RNA Purification Kit by Vitrosens Biotechnology Inc. — 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
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- 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
- Nucleic Acid Extraction Kit — Bioteke Corporation (Wuxi) Co., Ltd. · Class A
- MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A
- Pathogen DNA/RNA Extraction Kit (Magnetic Bead Method) — JIANGSU BIOPERFECTUS TECHNOLOGIES CO., 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 | 868354825VIRA03P100ES | Class A | Active |
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Manufacturer
- Manufacturer
- Vitrosens Biotechnology Inc.
- EUDAMED SRN
- TR-MF-000026452
Sources (2)
- EUDAMED de23763e-4d6f-4016-ad2d-82edae9a30d1 61 fields · synced Jul 19, 2026
- EUDAMED e88f94c1-9e3b-44af-a19b-f0bbd5e50da4 61 fields · synced May 17, 2026