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HPV DNA Extraction Kit HD01T-96
EUDAMEDClass A (EU MDR)
Ref 1000028433Model HD01T-96
Identity
- Trade Name
- HPV DNA Extraction Kit HD01T-96 EUDAMED
- Device Name
- HPV DNA Extraction Kit EUDAMED
- Model / Reference
- HD01T-96 EUDAMED1000028433 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974318130541 EUDAMED
- Basic UDI-DI
- 697431813HPV-Kit32 EUDAMED
- Direct Marketing DI
- 06974318130541 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
- Latvia 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
HPV DNA Extraction Kit HD01T-96 by Wuhan MGI Tech Co., Ltd. — 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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- MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A
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 | 697431813HPV-Kit32 | Class A | Active |
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Manufacturer
- Manufacturer
- Wuhan MGI Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000018732
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 85ae7331-4ce8-44a0-90e2-b4491852aade 61 fields · synced Sep 18, 2026