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Calcium
EUDAMEDClass B (EU MDR)
Ref 1415-0200Ref 1516-0200Ref 1418-0207Ref 1419-0201
Identity
- Trade Name
- CALCIUM EUDAMED
- Device Name
- CALCIUM EUDAMED
- Model / Reference
- 1415-0200 EUDAMED1516-0200 EUDAMED1418-0207 EUDAMED1419-0201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05204309167371 EUDAMED05204309175376 EUDAMED05204309039883 EUDAMED05204309115471 EUDAMED
- Basic UDI-DI
- 5204309000012NH EUDAMED
- Direct Marketing DI
- 05204309167371 EUDAMED05204309039883 EUDAMED05204309115471 EUDAMED
- EMDN Code
- W01010303 CALCIUM EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Greece 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
Calcium by Medicon Hellas SA — Class B — 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 | 5204309000012NH | Class B | Active |
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Manufacturer
- Manufacturer
- Medicon Hellas SA
- EUDAMED SRN
- GR-MF-000013625
Sources (4)
- EUDAMED 524f5642-95ba-41a1-b829-66710b58a5ce 61 fields · synced Jul 29, 2026
- EUDAMED 89a92ece-4e3c-48af-bace-f1657e72431a 61 fields · synced May 17, 2026
- EUDAMED 34927953-839b-42fc-9194-49e615f3b2af 61 fields · synced May 18, 2026
- EUDAMED a8cf7f8f-dd46-4816-a151-01f8d3664b20 61 fields · synced Jul 29, 2026