Identity
- Trade Name
- Lumbosacral Support S/M: Up to 30cm depth EUDAMED
- Device Name
- Orthosis EUDAMED
- Model / Reference
- H11A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060598933093 EUDAMED
- Basic UDI-DI
- 506059893TF40006V EUDAMED
- Direct Marketing DI
- 05060598933093 EUDAMED
- EMDN Code
- Y060308 LUMBOSACRAL SPINE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Lumbosacral Support S/M: Up to 30cm depth 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 | 506059893TF40006V | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medigarments Ltd
- EUDAMED SRN
- UK-MF-000037313
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 07b09ae0-f7d0-4422-96c7-dfc9bc007b8f 61 fields · synced Jul 9, 2026