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Specimen Preservation Solution
EUDAMEDClass A (EU MDR)
Ref DA0982Ref DA0987Ref DA0984
Identity
- Device Name
- Specimen Preservation Solution EUDAMED
- Model / Reference
- DA0982 EUDAMEDDA0987 EUDAMEDDA0984 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06928103009826 EUDAMED06928103009871 EUDAMED06928103009840 EUDAMED
- Basic UDI-DI
- 69281030098XFY 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 Solution 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 | 69281030098XFY | 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 (3)
- EUDAMED d302b0b4-4447-4fb8-ae59-f454d71316c3 61 fields · synced Jul 22, 2026
- EUDAMED 5a16bc4f-9c05-4834-9fcd-a47ce190f6a0 61 fields · synced May 19, 2026
- EUDAMED 80f857a7-6180-4ec6-8d4c-1e7e141f40b3 61 fields · synced May 19, 2026