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Round Adjustable Plate
EUDAMEDClass I (EU MDR)
Ref 4P22-RModel Prosthetic Knee Systems
Identity
- Trade Name
- Round Adjustable Plate EUDAMED
- Model / Reference
- Prosthetic Knee Systems EUDAMED4P22-R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978867213861 EUDAMED
- Basic UDI-DI
- 697886721PK000RM EUDAMED
- Direct Marketing DI
- 06978867213861 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
Round Adjustable Plate 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 5ef83da3-2c8e-43e8-b878-064c05eac92b 61 fields · synced Jul 15, 2026