Identity
- Trade Name
- Arm Gaiter Deluxe (XS - XL) EUDAMED
- Device Name
- Orthosis EUDAMED
- Model / Reference
- AG15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060598933130 EUDAMED
- Basic UDI-DI
- 506059893TF40006V EUDAMED
- Direct Marketing DI
- 05060598933130 EUDAMED
- EMDN Code
- Y060615 ELBOW 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
Arm Gaiter Deluxe (XS - XL) 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 bbde1e79-8cf0-4799-b467-7b36bd2a2ae5 61 fields · synced Jul 13, 2026