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Smart Seal Liner without Lock
EUDAMEDClass I (EU MDR)
Ref GCL-SAFR Model Prosthetic Knee SystemsRef GCL-SBFR
Identity
- Trade Name
- Smart Seal Liner without Lock EUDAMEDSmart Seal Liner without Lock II EUDAMED
- Model / Reference
- Prosthetic Knee Systems EUDAMEDGCL-SAFR EUDAMEDGCL-SBFR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978867212291 EUDAMED06978867212307 EUDAMED
- Basic UDI-DI
- 697886721PK000RM EUDAMED
- Direct Marketing DI
- 06978867212291 EUDAMED06978867212307 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
Smart Seal 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 (2)
- EUDAMED 0ac7443a-08b9-4eb7-bf90-c9486bccde56 61 fields · synced Jul 11, 2026
- EUDAMED 94ce5b21-ac0c-4a2e-820f-2629e09884f6 61 fields · synced May 18, 2026