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Rotator with Male Adaptor
EUDAMEDClass I (EU MDR)
Ref 4P60Model Prosthetic Knee SystemsRef 4P60-1
Identity
- Trade Name
- Rotator with Male Adaptor EUDAMEDRotator with Male Adaptor II EUDAMED
- Model / Reference
- Prosthetic Knee Systems EUDAMED4P60 EUDAMED4P60-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978867212857 EUDAMED06978867212864 EUDAMED
- Basic UDI-DI
- 697886721PK000RM EUDAMED
- Direct Marketing DI
- 06978867212857 EUDAMED06978867212864 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
Rotator with Male Adaptor 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 d5f20ceb-987d-4d76-96bb-ea6d6f91b8e2 61 fields · synced Aug 4, 2026
- EUDAMED 732e7af5-4199-4426-98e9-dff8d141b0a8 61 fields · synced May 17, 2026