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Nucleic Acid Isolation or Purification Reagent
EUDAMEDClass A (EU MDR)
Ref DA0623Ref DA0620
Identity
- Device Name
- Nucleic Acid Isolation or Purification Reagent EUDAMED
- Model / Reference
- DA0623 EUDAMEDDA0620 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06928103006238 EUDAMED06928103006207 EUDAMED
- Basic UDI-DI
- 69281030062XEX 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
Yes
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 Reagent 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 | 69281030062XEX | 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 43eced44-5a01-44be-b086-723fdd312a55 61 fields · synced Jul 31, 2026
- EUDAMED 21deb205-3770-4dd0-9c3a-d8a37ffefc13 61 fields · synced May 17, 2026