← Back to catalogue
Ankle Joint with Dual Assistive Force
EUDAMEDClass I (EU MDR)
Ref 8-401Model Orthotic Components
Identity
- Trade Name
- Ankle Joint with Dual Assistive Force EUDAMED
- Model / Reference
- Orthotic Components EUDAMED8-401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978867217968 EUDAMED
- Basic UDI-DI
- 697886721OC000PJ EUDAMED
- Direct Marketing DI
- 06978867217968 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
Ankle Joint with Dual Assistive Force 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 | 697886721OC000PJ | 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 3f0a2be4-c841-45df-b639-f3f0f64deb09 61 fields · synced Jun 18, 2026