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Sach Foot Adaptor II
EUDAMEDClass I (EU MDR)
Ref 2R8=M10-IIModel Prosthetic Ankle and Foot Systems
Identity
- Trade Name
- Sach Foot Adaptor II EUDAMED
- Model / Reference
- Prosthetic Ankle and Foot Systems EUDAMED2R8=M10-II EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978867215254 EUDAMED
- Basic UDI-DI
- 697886721AF000KD EUDAMED
- Direct Marketing DI
- 06978867215254 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
Sach Foot Adaptor II 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 | 697886721AF000KD | 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 0fd1bd9d-4be0-473b-9294-bd0c7fa0137e 61 fields · synced Jun 18, 2026