Identity
- Trade Name
- Heel Keeper AFO EUDAMED
- Device Name
- Heel Keeper AFO EUDAMED
- Model / Reference
- HKAF2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00199284923614 EUDAMED
- Basic UDI-DI
- 30181875HKAF2CK EUDAMED
- EMDN Code
- V0811 HEEL, ELBOW AND KNEE ANTI-DECUBITUS PROTECTION AIDS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Heel Keeper AFO by Ulcer Solutions — 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 | 30181875HKAF2CK | Class I | Active |
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Manufacturer
- Manufacturer
- Ulcer Solutions
- EUDAMED SRN
- US-MF-000036842
- Authorised Representative
- Code of Practice AB SE-AR-000003002
Sources (1)
- EUDAMED 64b6a7a2-5819-4d2f-9811-d0905ab25b45 61 fields · synced Jul 27, 2026