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SDO® Gauntlet to below elbow with 0 - 4 panels
EUDAMEDClass I (EU MDR)
Ref PCP13
Identity
- Trade Name
- SDO® Gauntlet to below elbow with 0 - 4 panels EUDAMED
- Device Name
- SDO Sensory Dynamic Orthosis EUDAMED
- Model / Reference
- PCP13 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060598930931 EUDAMED
- Basic UDI-DI
- 506059893TF60007B EUDAMED
- Direct Marketing DI
- 05060598930931 EUDAMED
- EMDN Code
- Y060609 WRIST (FOREARM) ORTHOSES 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
SDO® Gauntlet to below elbow with 0 - 4 panels 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 | 506059893TF60007B | 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 bdfafb64-34c9-4693-8cfb-00808b8deda7 61 fields · synced Jul 22, 2026