Identity
- Trade Name
- D-DIMER EUDAMED
- Device Name
- D-DIMER EUDAMED
- Model / Reference
- 1415-1182 EUDAMED1419-1182 EUDAMED1418-1180 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05204309167692 EUDAMED05204309119714 EUDAMED05204309086948 EUDAMED
- Basic UDI-DI
- 5204309000020NG EUDAMED
- EMDN Code
- W0103020503 D-DIMER EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
D-Dimer by Medicon Hellas SA — Class C — 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 | 5204309000020NG | Class C | Active |
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Manufacturer
- Manufacturer
- Medicon Hellas SA
- EUDAMED SRN
- GR-MF-000013625
Sources (3)
- EUDAMED 2a3ad96b-3d4e-4b1f-a533-ec34a0ac4e85 61 fields · synced Jul 16, 2026
- EUDAMED 1adddbcb-0e37-4410-b60f-dd803df7b756 61 fields · synced May 18, 2026
- EUDAMED 69561cfd-bb08-49c7-b9e2-14d2a6ab08bb 61 fields · synced May 18, 2026