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Curved Gel Sleeve
EUDAMEDClass I (EU MDR)
Ref GCL-SFXModel Prosthetic Knee Systems
Identity
- Trade Name
- Curved Gel Sleeve EUDAMED
- Model / Reference
- Prosthetic Knee Systems EUDAMEDGCL-SFX EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978867212444 EUDAMED
- Basic UDI-DI
- 697886721PK000RM EUDAMED
- Direct Marketing DI
- 06978867212444 EUDAMED
- EMDN Code
- Y062499 LOWER EXTREMITY PROSTHESES - 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
Curved Gel Sleeve 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 | 697886721PK000RM | 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 (1)
- EUDAMED a8114ec6-4d7d-4836-b2ea-7961f1c8c061 61 fields · synced Jun 19, 2026