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Nucleic Acid Isolation or Purification Kit
EUDAMEDClass A (EU MDR)
Ref DA0871Ref DA0870
Identity
- Device Name
- Nucleic Acid Isolation or Purification Kit EUDAMED
- Model / Reference
- DA0871 EUDAMEDDA0870 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06928103008713 EUDAMED06928103008706 EUDAMED
- Basic UDI-DI
- 69281030087XFQ 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
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
Nucleic Acid Isolation 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 | 69281030087XFQ | 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 (2)
- EUDAMED 164f4fa4-b3cf-4c64-89c7-55e5f72dafd1 61 fields · synced Jul 24, 2026
- EUDAMED 689350d4-95ca-49ff-8f24-1188988270e1 61 fields · synced May 19, 2026