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Superior Performance Gel Liner without Lock
EUDAMEDClass I (EU MDR)
Ref GCL-SPFR Model Prosthetic Knee Systems
Identity
- Trade Name
- Superior Performance Gel Liner without Lock EUDAMED
- Model / Reference
- Prosthetic Knee Systems EUDAMEDGCL-SPFR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978867212338 EUDAMED
- Basic UDI-DI
- 697886721PK000RM EUDAMED
- Direct Marketing DI
- 06978867212338 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
Superior Performance Gel Liner without Lock 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 b470e1b2-2087-4cd8-b21b-9e5b3feb0d39 61 fields · synced Jun 19, 2026