Identity
- Trade Name
- Soft healing cap EUDAMEDPonto FDA UDI
- Generic Name
- Skin treatment/dressing-supportive limb/finger bandage, single-use FDA UDI
- Device Name
- Healing Cap EUDAMEDSoft healing cap FDA UDI
- Model / Reference
- M52080 EUDAMEDFDA UDI
- Description
- Soft healing cap FDA UDI
Identifiers
- Catalog Number
- M52080 FDA UDI
- Primary DI / UDI-DI
- 05712149008858 EUDAMEDFDA UDI
- Basic UDI-DI
- 5712149100098J EUDAMED
- FDA Product Code
- MAH FDA UDI
- EMDN Code
- Q030399 INSTRUMENTS FOR ENT SURGERY, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Skin treatment/dressing-supportive limb/finger bandage, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3302 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Soft healing cap by Oticon Medical AB — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5712149100098J | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Oticon Medical AB
- EUDAMED SRN
- SE-MF-000000724
Sources (2)
- EUDAMED 01fb795b-c66d-4c64-85b2-26763561f529 61 fields · synced Jun 20, 2026
- FDA UDI f5d9ba93-0f00-46da-906b-a977d3980e35 35 fields · synced May 26, 2026