Identity
- Trade Name
- SDO® Lite Left Gauntlet 15-18cm EUDAMED
- Device Name
- SDO Lite MTO EUDAMED
- Model / Reference
- SDOL43 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060598930689 EUDAMED
- Basic UDI-DI
- 506059893TF60017D EUDAMED
- Direct Marketing DI
- 05060598930689 EUDAMED
- EMDN Code
- M030499 ELASTIC BANDAGES, SUPPORT AND COMPRESSION - 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
Category: Compression/pressure sock/stocking, reusable
SDO® Lite Left Gauntlet 15-18cm by Medigarments Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Compression/pressure sock/stocking, reusable.
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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 | 506059893TF60017D | 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 3e316ca7-e99e-4469-b231-c1e0f4110fdd 61 fields · synced Jul 15, 2026