Identity
- Trade Name
- MTM Leg Flexion Gaiter EUDAMED
- Device Name
- Orthosis EUDAMED
- Model / Reference
- HNS58F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060598933154 EUDAMED
- Basic UDI-DI
- 506059893TF40006V EUDAMED
- Direct Marketing DI
- 05060598933154 EUDAMED
- EMDN Code
- Y061209 KNEE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
MTM Leg Flexion Gaiter by Medigarments 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 | 506059893TF40006V | Class I | Active |
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Manufacturer
- Manufacturer
- Medigarments Ltd
- EUDAMED SRN
- UK-MF-000037313
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 93ac2f1d-5c27-4a8e-85a9-ea8e062d7355 61 fields · synced Jul 11, 2026