Identity
- Trade Name
- Healing cap EUDAMED
- Device Name
- Healing Cap EUDAMED
- Model / Reference
- M50821 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05712149002757 EUDAMED
- Basic UDI-DI
- 5712149100098J EUDAMED
- EMDN Code
- Q030399 INSTRUMENTS FOR ENT SURGERY, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
Yes
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
Healing cap by Oticon Medical AB — 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 | 5712149100098J | Class I | Active |
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Manufacturer
- Manufacturer
- Oticon Medical AB
- EUDAMED SRN
- SE-MF-000000724
Sources (1)
- EUDAMED e69e8145-392e-4580-908c-895e36db3771 61 fields · synced Jun 18, 2026