Identity
- Trade Name
- Vitassay Microorganism-NA isolation kit EUDAMED
- Device Name
- Vitassay Microorganism-NA isolation kit EUDAMED
- Model / Reference
- 7071001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436592683901 EUDAMED
- Basic UDI-DI
- 84365926PCR_7071001L4 EUDAMED
- Direct Marketing DI
- 08436592683901 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
- Spain 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
Vitassay Microorganism-NA isolation kit by Vitassay Healthcare S.l. — 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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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 | 84365926PCR_7071001L4 | Class A | Active |
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Manufacturer
- Manufacturer
- Vitassay Healthcare S.l.
- EUDAMED SRN
- ES-MF-000030959
Sources (1)
- EUDAMED d674ea49-a4d1-4adc-a31a-6e68c33fff60 61 fields · synced Jun 20, 2026