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Specimen Preservation Reagent
EUDAMEDClass A (EU MDR)
Ref DA0975Ref DA0977Ref DA0974Ref DA0978Ref DA0976Ref DA0979Ref DA0970Ref DA0971Ref DA0973
Identity
- Device Name
- Specimen Preservation Reagent EUDAMED
- Model / Reference
- DA0975 EUDAMEDDA0977 EUDAMEDDA0974 EUDAMEDDA0978 EUDAMEDDA0976 EUDAMEDDA0979 EUDAMEDDA0970 EUDAMEDDA0971 EUDAMEDDA0973 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06928103009758 EUDAMED06928103009772 EUDAMED06928103009741 EUDAMED06928103009789 EUDAMED06928103009765 EUDAMED06928103009796 EUDAMED06928103009703 EUDAMED06928103009710 EUDAMED06928103009734 EUDAMED
- Basic UDI-DI
- 69281030097XFV EUDAMED
- EMDN Code
- W05020199 SAMPLES TRANSPORT, CONTAINERS - 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
Specimen Preservation 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 | 69281030097XFV | 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 501f092c-2345-4d9b-88db-67b109f0f50f 61 fields · synced Aug 1, 2026
- EUDAMED 3a2df37a-7b51-4c35-a661-723d0f7a9558 61 fields · synced May 17, 2026
- EUDAMED 09b4c3bd-094e-4768-86da-eedb575c129f 61 fields · synced May 17, 2026
- EUDAMED 2a024a10-4ed6-48bf-967d-bb4eeaa6d7a5 61 fields · synced May 17, 2026
- EUDAMED ab67d0f0-1fb6-4e73-beb1-366c5624103c 61 fields · synced May 17, 2026
- EUDAMED d5b6d9ad-5dfb-4d02-80cb-93a537403716 61 fields · synced May 18, 2026
- EUDAMED 2f39f76f-4e07-4cae-b754-db8831803d3a 61 fields · synced May 18, 2026
- EUDAMED 6636f098-2cb4-4f9f-8d1e-ad2905e4a055 61 fields · synced May 18, 2026
- EUDAMED 71669cb1-51ad-4663-bb44-fd06658175ec 61 fields · synced May 19, 2026