Identity
- Trade Name
- Custom Structural Scoliosis Suit EUDAMED
- Device Name
- DMO Custom Structural Scoliosis Suit EUDAMED
- Model / Reference
- DM 38 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05054522000227 EUDAMED
- Basic UDI-DI
- 5054522000227QN EUDAMED
- Direct Marketing DI
- 05054522000227 EUDAMED
- EMDN Code
- Y060306 THORACOLUMBAR 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
Custom Structural Scoliosis Suit by DM Orthotics 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 | 5054522000227QN | Class I | Active |
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Manufacturer
- Manufacturer
- DM Orthotics Ltd
- EUDAMED SRN
- GB-MF-000008260
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED 9970c6c6-1e71-4e4f-bbb5-8bdfc13ca234 61 fields · synced Jul 12, 2026