Identity
- Trade Name
- Custom Glove/Gauntlet without Sleeve EUDAMED
- Device Name
- DMO Custom Glove/Gauntlet Without Sleeve EUDAMED
- Model / Reference
- DM 18 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05054522000135 EUDAMED
- Basic UDI-DI
- 50545220002135DA EUDAMED
- Direct Marketing DI
- 05054522000135 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
Custom Glove/Gauntlet without Sleeve 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 | 50545220002135DA | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DM Orthotics Ltd
- EUDAMED SRN
- GB-MF-000008260
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED e0a62c04-61ea-4b2a-afb3-98fcbf2b52f5 61 fields · synced Jun 18, 2026