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RNA/DNA Extraction or Purification Kit
EUDAMEDClass A (EU MDR)
Ref DA0661Ref DA1275Ref DA0642Ref DA0651Ref DA1273Ref DA0643Ref DA0641Ref DA0660Ref DA0650
Identity
- Device Name
- RNA/DNA Extraction or Purification Kit EUDAMED
- Model / Reference
- DA0661 EUDAMEDDA1275 EUDAMEDDA0642 EUDAMEDDA0651 EUDAMEDDA1273 EUDAMEDDA0643 EUDAMEDDA0641 EUDAMEDDA0660 EUDAMEDDA0650 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06928103006610 EUDAMED06928103012758 EUDAMED06928103006429 EUDAMED06928103006511 EUDAMED06928103012734 EUDAMED06928103006436 EUDAMED06928103006412 EUDAMED06928103006603 EUDAMED06928103006504 EUDAMED
- Basic UDI-DI
- 69281030066XFB EUDAMED69281030127XEZ EUDAMED69281030064XF5 EUDAMED69281030065XF8 EUDAMED
- EMDN Code
- W0599 IVD GENERAL USE CONSUMABLE DEVICES - 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
EUDAMEDEUDAMED
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
RNA/DNA Extraction or Purification Kit by Daan Gene 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 | 69281030066XFB | Class A | Active |
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Manufacturer
- Manufacturer
- Daan Gene Co., Ltd.
- EUDAMED SRN
- CN-MF-000025799
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (9)
- EUDAMED f32874b0-a310-4b0a-8ebd-ec908b0e6e8b 61 fields · synced Aug 1, 2026
- EUDAMED 93cf6149-4de2-46e7-a1fb-711413a7610d 61 fields · synced May 17, 2026
- EUDAMED 733aab46-6b4f-4724-a558-41a5c20364e1 61 fields · synced May 17, 2026
- EUDAMED bc674c92-d1a9-4a35-85ca-a9564d0e60ca 61 fields · synced May 17, 2026
- EUDAMED 6f47ae01-c4a9-4e1f-b568-24059b297541 61 fields · synced May 17, 2026
- EUDAMED 6021345a-c26e-4035-ba1e-d98a9486753d 61 fields · synced May 17, 2026
- EUDAMED 1604e6b2-dca9-4c93-8103-a34b84e1cc96 61 fields · synced May 18, 2026
- EUDAMED 64342c13-859e-4a0f-a179-b9e83c296590 61 fields · synced May 18, 2026
- EUDAMED 263e4acf-d9a5-4abe-a992-d1e16d87eb0a 61 fields · synced May 18, 2026