Identity
- Device Name
- AmpSure® HPV 16/18 Genotype Assay EUDAMED
- Model / Reference
- HPV1618RT2-100CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974737220854 EUDAMED
- Basic UDI-DI
- 697473722HPV1618RT25E EUDAMED
- EMDN Code
- W0105041003 PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Greece 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
AmpSure® HPV 16/18 Genotype Assay by Shanghai Rendu Biotechnology Co., Ltd. — 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 | 697473722HPV1618RT25E | Class C | Active |
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Manufacturer
- Manufacturer
- Shanghai Rendu Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000018869
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED ac32e6ba-3fa2-4622-a98d-52e13700640b 61 fields · synced Jul 29, 2026