Identity
- Trade Name
- Assista - Conuri pentruigiena urechilor EUDAMED
- Device Name
- Coni Auricolari EUDAMED
- Model / Reference
- COA009546 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05948567009546 EUDAMED
- Basic UDI-DI
- 8017990COAFK EUDAMED
- EMDN Code
- Q03040299 EAR IRRIGATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Assista - Conuri pentruigiena urechilor by Eurosirel Spa — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8017990COAFK | Class I | Active |
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Manufacturer
- Manufacturer
- Eurosirel Spa
- EUDAMED SRN
- IT-MF-000005982
Sources (1)
- EUDAMED 42d5a5d6-afcb-42d1-a23f-284549cec118 61 fields · synced Jul 25, 2026