Identity
- Trade Name
- The Gardiner Hand Surgery System EUDAMEDThe Gardiner Hand Surgery System - Hand Table Only EUDAMED
- Device Name
- Arm Procedure Positioner, Reusable EUDAMED
- Model / Reference
- 21380 EUDAMED21382 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051995008767 EUDAMED05051995008774 EUDAMED
- Basic UDI-DI
- 5051995ARMHANDSUPPORT4R EUDAMED
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern 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
The Gardiner Hand Surgery System by Anetic Aid 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 | 5051995ARMHANDSUPPORT4R | Class I | Active |
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Manufacturer
- Manufacturer
- Anetic Aid Ltd
- EUDAMED SRN
- GB-MF-000011932
- Authorised Representative
- EU-UK Authorised Representative Ltd XI-AR-000010192
Sources (2)
- EUDAMED b5e5237c-e122-4828-a237-f717500fe86f 61 fields · synced Jul 17, 2026
- EUDAMED 957a6ff1-be64-4968-b92a-0f28b894d2e7 61 fields · synced May 18, 2026