Identity
- Trade Name
- Swinger EUDAMED
- Device Name
- Swinger EUDAMED
- Model / Reference
- 3000078 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060639240814 EUDAMED
- Basic UDI-DI
- 506063924SwingerVS EUDAMED
- EMDN Code
- Y060680 UPPER LIMB ORTHOSES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Swinger by Open Bionics 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 | 506063924SwingerVS | Class I | Active |
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Manufacturer
- Manufacturer
- Open Bionics Ltd.
- EUDAMED SRN
- GB-MF-000032650
- Authorised Representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Sources (1)
- EUDAMED 00f4ba89-0404-43de-9025-a95a1036a71d 61 fields · synced Jun 18, 2026