Identity
- Device Name
- Elastic tube orthoses EUDAMED
- Model / Reference
- UP5155M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060242684395 EUDAMED
- Basic UDI-DI
- 50602426851JU EUDAMED
- EMDN Code
- Y06121201 PASSIVE KNEE-ANKLE-FOOT ORTHOSES 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
Elastic tube orthoses 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 | 50602426851JU | Class I | Active |
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Manufacturer
- Manufacturer
- Burton McCall Ltd
- EUDAMED SRN
- UK-MF-000051789
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED a5edf1f8-9dc0-475e-8c99-0b0a2f65070b 61 fields · synced Jun 18, 2026