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Neoprene tube orthoses with straps and deformable insert
EUDAMEDClass I (EU MDR)
Ref UP5441PRef UP5441MRef UP5450Ref UP5430RRef UP5430LRef UP5441RRef UP5460Ref UP5441B
Identity
- Device Name
- Neoprene tube orthoses with straps and deformable insert EUDAMED
- Model / Reference
- UP5441P EUDAMEDUP5441M EUDAMEDUP5450 EUDAMEDUP5430R EUDAMEDUP5430L EUDAMEDUP5441R EUDAMEDUP5460 EUDAMEDUP5441B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060242686863 EUDAMED05060242686849 EUDAMED05060242681882 EUDAMED05060242681851 EUDAMED05060242681868 EUDAMED05060242686870 EUDAMED05060242681899 EUDAMED05060242686832 EUDAMED
- Basic UDI-DI
- 50602426854K2 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 deformable 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 | 50602426854K2 | 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 (8)
- EUDAMED 1956509e-eaa0-48be-9beb-da5d2cf53770 61 fields · synced Jul 31, 2026
- EUDAMED 323ac543-5506-4be9-b12f-72530aab7daf 61 fields · synced May 16, 2026
- EUDAMED a3fff809-48c6-41ce-bcc7-ccd9ac4b8cf8 61 fields · synced May 16, 2026
- EUDAMED 9e2c912e-1466-40c2-a0bb-4a1ac0cdbc9b 61 fields · synced May 17, 2026
- EUDAMED cd479e16-0350-4895-b169-8836c8956363 61 fields · synced May 18, 2026
- EUDAMED 29442a80-9435-419b-9f7d-ff7d3a3cf247 61 fields · synced May 18, 2026
- EUDAMED d32ce4f8-9d07-4467-b229-57e6f1334f19 61 fields · synced May 18, 2026
- EUDAMED 07161eaf-9a7b-4893-b356-bd7a47e6d480 61 fields · synced May 19, 2026