← Back to catalogue
Nucleic Acid Isolation or Purification Reagent
EUDAMEDClass A (EU MDR)
Ref DA0622
Identity
- Device Name
- Nucleic Acid Isolation or Purification Reagent EUDAMED
- Model / Reference
- DA0622 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06928103006221 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Daan Gene Co., Ltd.
- EUDAMED SRN
- CN-MF-000025799
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED e5e67444-1293-4d52-9dc2-91f214460aa5 61 fields · synced Jun 18, 2026