← Back to catalogue
Crystal ROM Liner Walker
EUDAMEDClass I (EU MDR)
Ref 4013Model Lower Limb Orthoses
Identity
- Trade Name
- Crystal ROM Liner Walker EUDAMED
- Model / Reference
- Lower Limb Orthoses EUDAMED4013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978867217142 EUDAMED
- Basic UDI-DI
- 697886721LO000R5 EUDAMED
- Direct Marketing DI
- 06978867217142 EUDAMED
- EMDN Code
- Y0699 EXTERNAL PROSTHESES AND ORTHOSES - 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
Crystal ROM Liner Walker by Medi Global Assistive Device Co., 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 | 697886721LO000R5 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medi Global Assistive Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000034804
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (1)
- EUDAMED ab02f5db-d91d-46b4-85d2-427f32d8c4da 61 fields · synced Jun 20, 2026