Identity
- Trade Name
- Akso HPV Real-time PCR Kit EUDAMED
- Device Name
- Akso HPV Real-time PCR Kit EUDAMED
- Model / Reference
- RT6003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954414746914 EUDAMED
- Basic UDI-DI
- 695441479704KN EUDAMED
- EMDN Code
- W0105041004 FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
Akso HPV Real-time PCR Kit by Getein Biotech, Inc. — Class C — 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 | 695441479704KN | Class C | Active |
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Manufacturer
- Manufacturer
- Getein Biotech, Inc.
- EUDAMED SRN
- CN-MF-000017986
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 57e68765-e9b2-4ef5-9318-49402060faea 61 fields · synced Jul 24, 2026