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RGO Components
EUDAMEDClass I (EU MDR)
Ref 29-11Model Orthotic ComponentsRef 29-01
Identity
- Trade Name
- RGO Components EUDAMEDRGO Components Knee Joint with Pneumatic Force EUDAMED
- Model / Reference
- Orthotic Components EUDAMED29-11 EUDAMED29-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978867217777 EUDAMED06978867217784 EUDAMED
- Basic UDI-DI
- 697886721OC000PJ EUDAMED
- Direct Marketing DI
- 06978867217777 EUDAMED06978867217784 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
RGO Components 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 |
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Manufacturer
- Manufacturer
- Medi Global Assistive Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000034804
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (2)
- EUDAMED 4f10ce57-06a2-483b-931f-87817424da35 61 fields · synced Jul 22, 2026
- EUDAMED 4b51b73d-bd50-47dc-8286-47b0f93790a4 61 fields · synced May 18, 2026