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8 1/4 in Myo Kinisi Myoelectric hand RIGHT with EU wrist
EUDAMEDClass I (EU MDR)
Ref KIN825REU
Identity
- Trade Name
- 8 1/4 in Myo Kinisi Myoelectric hand RIGHT with EU wrist EUDAMED
- Device Name
- Myoelectric hand prosthesis EUDAMED
- Model / Reference
- KIN825REU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 50563943002074 EUDAMED
- Basic UDI-DI
- 50553482ELH0007U EUDAMED
- EMDN Code
- Y061899 UPPER EXTREMITY PROSTHESES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
8 1/4 in Myo Kinisi Myoelectric hand RIGHT with EU wrist by Hugh Steeper Limited — 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 | 50553482ELH0007U | Class I | Active |
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Manufacturer
- Manufacturer
- Hugh Steeper Limited
- EUDAMED SRN
- GB-MF-000010196
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 3876e6c7-bf40-464e-ad6a-e4f69df0b687 61 fields · synced Oct 7, 2026