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SDO® Leotard with/without sleeves and 0 - 4 panels
EUDAMEDClass I (EU MDR)
Ref SDO02Ref PCP02
Identity
- Trade Name
- SDO® Leotard with/without sleeves and 0 - 4 panels EUDAMED
- Device Name
- SDO Sensory Dynamic Orthosis EUDAMED
- Model / Reference
- SDO02 EUDAMEDPCP02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060598933598 EUDAMED05060598930900 EUDAMED
- Basic UDI-DI
- 506059893TF60007B EUDAMED
- Direct Marketing DI
- 05060598933598 EUDAMED05060598930900 EUDAMED
- EMDN Code
- Y060699 ORTHOSES, UPPER EXTREMITY - OTHER 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® Leotard with/without sleeves and 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 (2)
- EUDAMED 00a28cff-df65-49a4-983a-fb348414a2e2 61 fields · synced Jul 29, 2026
- EUDAMED e8834904-dcaf-4ad7-ba16-31700d6e8fcb 61 fields · synced May 18, 2026