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viRNAtrap DNAPlusTM Extraction KIT (PN 3315-500)
EUDAMEDClass A (EU MDR)
Ref 3315-500Model nucleic acid extraction 3315-500
Identity
- Trade Name
- viRNAtrap DNAPlusTM Extraction KIT (PN 3315-500) EUDAMED
- Device Name
- viRNAtrap DNAPlusTM Extraction KIT EUDAMED
- Model / Reference
- nucleic acid extraction 3315-500 EUDAMED3315-500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15099590775155 EUDAMED
- Basic UDI-DI
- 1509959053315-500EW EUDAMED
- EMDN Code
- W02069085 VARIOUS SAMPLE PROCESSING INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Czechia 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
viRNAtrap DNAPlusTM Extraction KIT (PN 3315-500) by IMMUNOTECH s.r.o. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 1509959053315-500EW | Class A | Active |
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Manufacturer
- Manufacturer
- IMMUNOTECH s.r.o.
- EUDAMED SRN
- CZ-MF-000001761
Sources (1)
- EUDAMED d7b737bd-808d-49ad-8fd6-e76afe1448d9 61 fields · synced Sep 17, 2026