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ViraSens Genomic DNA Purification From Bacteria
EUDAMEDClass A (EU MDR)
Ref VIRA04Model VIRA04P100
Identity
- Trade Name
- ViraSens Genomic DNA Purification From Bacteria EUDAMED
- Device Name
- Genomic DNA Purification From Bacteria EUDAMED
- Model / Reference
- VIRA04P100 EUDAMEDVIRA04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683548253552 EUDAMED
- Basic UDI-DI
- 868354825VIRA04P100F5 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 Genomic DNA Purification From Bacteria by Vitrosens Biotechnology Inc. — 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
- 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 | 868354825VIRA04P100F5 | Class A | Active |
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Manufacturer
- Manufacturer
- Vitrosens Biotechnology Inc.
- EUDAMED SRN
- TR-MF-000026452
Sources (1)
- EUDAMED 73f22e97-f173-4e6f-9ad5-98941c0ad1d8 61 fields · synced Jun 18, 2026