← Back to catalogue
Heel Keeper Ultra
EUDAMEDClass I (EU MDR)
Ref HG01ULTRAXLModel Heel Keeper Ultra StandardRef HG01ULTRA
Identity
- Trade Name
- Heel Keeper Ultra EUDAMED
- Device Name
- Heel Keeper Ultra EUDAMED
- Model / Reference
- Heel Keeper Ultra Standard EUDAMEDHG01ULTRAXL EUDAMEDHG01ULTRA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00199874015408 EUDAMED00199874501697 EUDAMED
- Basic UDI-DI
- 30181875HG01ULTRANY 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 Ultra 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 | 30181875HG01ULTRANY | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ulcer Solutions
- EUDAMED SRN
- US-MF-000036842
- Authorised Representative
- Code of Practice AB SE-AR-000003002
Sources (2)
- EUDAMED 8ea64e8f-cafd-4170-88aa-fc6836e50d7f 61 fields · synced Jul 26, 2026
- EUDAMED e706eb58-db41-4750-8ca3-e807e6724cbf 61 fields · synced May 18, 2026