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Nucleic Acid Genotyping Kit for Human Papillomavirus 18 types (Flowcytometry Fl…
EUDAMEDClass IVD General (EU MDR)
Ref 2HPV18A01
Identity
- Trade Name
- Nucleic Acid Genotyping Kit for Human Papillomavirus 18 types (Flowcytometry Fluorescence Hybridization Method) EUDAMED
- Device Name
- Nucleic Acid Genotyping Kit for Human Papillomavirus 18 types (Flowcytometry Fluorescence Hybridization Method) EUDAMED
- Model / Reference
- 2HPV18A01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810173656931 EUDAMED
- Basic UDI-DI
- B-00810173656931 EUDAMED
- EMDN Code
- W0105041003 PARTIAL GENOTYPING HIGH-RISK 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 18 types (Flowcytometry Fl… by Healgen Scientific Limited Liability Company — Class IVD General — CE/MDR…
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 | B-00810173656931 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Healgen Scientific Limited Liability Company
- EUDAMED SRN
- US-MF-000018839
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 3dd59155-3512-469e-84c1-bd66f453b5a6 61 fields · synced Oct 6, 2026