Identity
- Trade Name
- Custom Glove/Gauntlet with separate Sleeve EUDAMED
- Device Name
- DMO Custom Glove/Gauntlet with Separate Sleeve EUDAMED
- Model / Reference
- DM 16 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05054522000111 EUDAMED
- Basic UDI-DI
- 5054522000111Q2 EUDAMED
- Direct Marketing DI
- 05054522000111 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 with separate 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 | 5054522000111Q2 | 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 0ec533e1-6ffd-46f8-a701-f4a6e19bc342 61 fields · synced Jul 10, 2026