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Ace
EUDAMEDClass B (EU MDR)
Ref 1417-1160Ref 1415-1160Ref 1418-1161Ref 1419-1162
Identity
- Trade Name
- ACE EUDAMED
- Device Name
- ACE EUDAMED
- Model / Reference
- 1417-1160 EUDAMED1415-1160 EUDAMED1418-1161 EUDAMED1419-1162 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05204309137527 EUDAMED05204309167555 EUDAMED05204309168118 EUDAMED05204309120963 EUDAMED
- Basic UDI-DI
- 5204309000002NE EUDAMED
- EMDN Code
- W01010109 ANGIOTENSIN CONVERTING ENZYME (CC) 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
Ace 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 | 5204309000002NE | Class B | Active |
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Manufacturer
- Manufacturer
- Medicon Hellas SA
- EUDAMED SRN
- GR-MF-000013625
Sources (4)
- EUDAMED bdd3e31d-852d-4047-8202-4c6277116a76 61 fields · synced Jul 17, 2026
- EUDAMED 7a7a03ce-0b84-47ac-884e-e76399aa9ff6 61 fields · synced May 17, 2026
- EUDAMED a8e4c41d-a0ef-4814-8066-a68679257b81 61 fields · synced May 17, 2026
- EUDAMED 3b35c74c-82a9-4cfd-990c-d4755dc71f85 61 fields · synced May 18, 2026