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Fast Change Adaptor with Pyramid
EUDAMEDClass I (EU MDR)
Ref MD-FCA1Model Prosthetic Knee SystemsRef MD-FCA2
Identity
- Trade Name
- Fast Change Adaptor with Pyramid EUDAMEDFast Change Adaptor with Pyramid Receiver EUDAMED
- Model / Reference
- Prosthetic Knee Systems EUDAMEDMD-FCA1 EUDAMEDMD-FCA2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978867213892 EUDAMED06978867213908 EUDAMED
- Basic UDI-DI
- 697886721PK000RM EUDAMED
- Direct Marketing DI
- 06978867213892 EUDAMED06978867213908 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
Fast Change Adaptor with Pyramid 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 426bf17e-0caa-4e57-bc0c-471888d8befc 61 fields · synced Jul 30, 2026
- EUDAMED d16adf35-c11a-4c60-bec5-97e350567d92 61 fields · synced May 18, 2026