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Nucleic Acid Genotyping Kit for Human Papillomavirus 29 types(Flowcytometry Flu…
EUDAMEDClass IVD General (EU MDR)
Ref 2HPV29A11
Identity
- Trade Name
- Nucleic Acid Genotyping Kit for Human Papillomavirus 29 types(Flowcytometry Fluorescence Hybridization Method) EUDAMED
- Device Name
- Nucleic Acid Genotyping Kit for Human Papillomavirus 29 types(Flowcytometry Fluorescence Hybridization Method) EUDAMED
- Model / Reference
- 2HPV29A11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950996004480 EUDAMED
- Basic UDI-DI
- B-06950996004480 EUDAMED
- EMDN Code
- W0105041005 OTHER HPV - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
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
Nucleic Acid Genotyping Kit for Human Papillomavirus 29 types(Flowcytometry Flu… by Zhejiang Orient Gene Biotech Co., Ltd — Class IVD General — IVDD — listed…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06950996004480 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zhejiang Orient Gene Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000017965
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 717ccba2-2400-4153-94cc-21de016a9ab9 61 fields · synced Jun 18, 2026