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7 3/4in Myo Kinisi Myoelectric hand RIGHT with EU wrist
EUDAMEDFDA UDIClass I (EU MDR)
Ref KIN775REU
Identity
- Trade Name
- 7 3/4in Myo Kinisi Myoelectric hand RIGHT with EU wrist EUDAMEDMYO FDA UDI
- Generic Name
- Myoelectric hand prosthesis FDA UDI
- Device Name
- Myoelectric hand prosthesis EUDAMED
- Model / Reference
- KIN775REU EUDAMED7 3/4in Myo Kinisi Myoelectric hand RIGHT with EU wrist FDA UDI
Identifiers
- Catalog Number
- KIN775REU FDA UDI
- Primary DI / UDI-DI
- 50563943001220 EUDAMED05056394300122 FDA UDI
- Basic UDI-DI
- 50553482ELH0007U EUDAMED
- FDA Product Code
- IQZ FDA UDI
- EMDN Code
- Y061899 UPPER EXTREMITY PROSTHESES - OTHER EUDAMED
- GMDN Term
- Myoelectric hand prosthesis FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3420 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
7 3/4in Myo Kinisi Myoelectric hand RIGHT with EU wrist by Hugh Steeper Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 50553482ELH0007U | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hugh Steeper Limited
- EUDAMED SRN
- GB-MF-000010196
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED f37b25c3-33a1-4e4a-920f-7028d08b6632 61 fields · synced Jun 18, 2026
- FDA UDI 4b8fd579-50e1-4cde-9c7a-e89a76497fe9 33 fields · synced May 30, 2026