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Neoprene tube orthoses with straps and hard/metallic insert
EUDAMEDClass I (EU MDR)
Ref 5515-3X
Identity
- Device Name
- Neoprene tube orthoses with straps and hard/metallic insert EUDAMED
- Model / Reference
- 5515-3X EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060242684654 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 a3a01a53-4d8f-41bc-8fb5-6dd063ecd26a 61 fields · synced Jun 18, 2026