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Reagent for removal of DNA contaminations
EUDAMEDClass A (EU MDR)
Ref 250mL/bottleRef 500mL/bottle
Identity
- Device Name
- Reagent for removal of DNA contaminations EUDAMED
- Model / Reference
- 250mL/bottle EUDAMED500mL/bottle EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974898111732 EUDAMED06974898111749 EUDAMED
- Basic UDI-DI
- 697489811000009ZL EUDAMED
- Direct Marketing DI
- 06974898111732 EUDAMED06974898111749 EUDAMED
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
Reagent for removal of DNA contaminations by Genfine Biotech(changzhou) 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 | 697489811000009ZL | Class A | Active |
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Manufacturer
- Manufacturer
- Genfine Biotech(changzhou) Co., Ltd
- EUDAMED SRN
- CN-MF-000003399
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED 3e788ab9-edc5-44a3-9f6d-3087d24256d3 61 fields · synced Jul 19, 2026
- EUDAMED a929afc0-c341-4bc2-a823-11d10dd23467 61 fields · synced May 17, 2026