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2112/Hemi
EUDAMEDClass I (EU MDR)
Ref 2112/HEMIModel BASIC WALKING FRAME - NON-FOLDABLE
Identity
- Model / Reference
- BASIC WALKING FRAME - NON-FOLDABLE EUDAMED2112/HEMI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055721201156 EUDAMED
- Basic UDI-DI
- 5055721231118UC EUDAMED
- EMDN Code
- Y120603 WALKING FRAMES, 4 TIPS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia 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
2112/Hemi by Roma Medical Aids — 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 | 5055721231118UC | Class I | Active |
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Manufacturer
- Manufacturer
- Roma Medical Aids
- EUDAMED SRN
- GB-MF-000013502
- Authorised Representative
- StartDock Rotterdam B.V. NL-AR-000012537
Sources (1)
- EUDAMED 97f90e96-8b95-4c65-8800-fd9b56f8182c 61 fields · synced Aug 4, 2026