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Neoprene tube orthoses with straps and hard/metallic insert
EUDAMEDClass I (EU MDR)
Ref UP5511R
Identity
- Device Name
- Neoprene tube orthoses with straps and hard/metallic insert EUDAMED
- Model / Reference
- UP5511R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060242688157 EUDAMED
- Basic UDI-DI
- 50602426855K4 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
Neoprene tube orthoses with straps and hard/metallic insert 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 | 50602426855K4 | 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 55638d51-7c15-4e7e-9096-0ac5fddff406 61 fields · synced Jun 18, 2026