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Virus DNA/RNA Kit(Magnetic Beads)
EUDAMEDClass A (EU MDR)
Ref 502-B: 96preps/boxRef 502-Y: 64preps/boxRef 502-Y: 480preps/boxRef 502-Y: 48preps/boxRef 502-B: 960preps/boxRef 502-B: 480preps/boxRef 502-Y: 10preps/boxRef 502-B: 50preps/boxRef 502-Y: 960preps/box
Identity
- Device Name
- Virus DNA/RNA Kit(Magnetic Beads) EUDAMED
- Model / Reference
- 502-B: 96preps/box EUDAMED502-Y: 64preps/box EUDAMED502-Y: 480preps/box EUDAMED502-Y: 48preps/box EUDAMED502-B: 960preps/box EUDAMED502-B: 480preps/box EUDAMED502-Y: 10preps/box EUDAMED502-B: 50preps/box EUDAMED502-Y: 960preps/box EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974898110902 EUDAMED06974898110858 EUDAMED06974898110872 EUDAMED06974898110841 EUDAMED06974898110926 EUDAMED06974898110919 EUDAMED06974898110803 EUDAMED06974898110896 EUDAMED06974898110889 EUDAMED
- Basic UDI-DI
- 697489811000002Z6 EUDAMED
- Direct Marketing DI
- 06974898110902 EUDAMED06974898110858 EUDAMED06974898110872 EUDAMED06974898110841 EUDAMED06974898110926 EUDAMED06974898110919 EUDAMED06974898110803 EUDAMED06974898110896 EUDAMED06974898110889 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
Virus DNA/RNA 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 | 697489811000002Z6 | 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 (9)
- EUDAMED ce0e836d-48ee-4106-a7d9-8a2ae709af65 61 fields · synced Oct 6, 2026
- EUDAMED 4ce03705-366f-4fe6-b1a4-a58e9039a7a1 61 fields · synced May 17, 2026
- EUDAMED 405848fe-ea7e-4c93-9d7e-d6a11282f5f9 61 fields · synced May 17, 2026
- EUDAMED e0af1fe8-4992-4bb5-9886-bf2c496d633c 61 fields · synced May 17, 2026
- EUDAMED bbd61de0-0227-4eb9-80b6-478e9478a082 61 fields · synced May 17, 2026
- EUDAMED c13eb7df-2e9b-4a60-a5c8-54a71afc47ab 61 fields · synced May 18, 2026
- EUDAMED cd23d365-98c3-44d7-b49a-673fa20425f1 61 fields · synced May 18, 2026
- EUDAMED 018fbcaf-8c75-4f17-a206-2e47e8963fad 61 fields · synced May 18, 2026
- EUDAMED ec3b40a6-d7ba-4954-a450-816e82314c09 61 fields · synced May 19, 2026