Identity
- Device Name
- Insoles EUDAMED
- Model / Reference
- UP4571M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060242688287 EUDAMED
- Basic UDI-DI
- 50602426845JZ EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Malta 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
Insoles by Burton McCall Ltd — 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 | 50602426845JZ | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Burton McCall Ltd
- EUDAMED SRN
- UK-MF-000051789
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED b59fa672-2398-4c45-bdc1-57fbd179bfaf 61 fields · synced Jun 18, 2026