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DNA/RNA Extraction Kit(Magnetic Beads)
EUDAMEDClass A (EU MDR)
Ref 403-Y: 480preps/box
Identity
- Device Name
- DNA/RNA Extraction Kit(Magnetic Beads) EUDAMED
- Model / Reference
- 403-Y: 480preps/box EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974898110537 EUDAMED
- Basic UDI-DI
- 697489811000001Z4 EUDAMED
- Direct Marketing DI
- 06974898110537 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
- 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
DNA/RNA Extraction Kit(Magnetic Beads) by Genfine Biotech(changzhou) Co., Ltd — Class A — 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 | 697489811000001Z4 | 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 (1)
- EUDAMED c36b6906-5a32-41a1-b288-0d5804036f5a 61 fields · synced Jun 20, 2026