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Spring Operated Hand 8 1/4 Right - 1/2 X 20 Tpi
EUDAMEDFDA UDIClass I (EU MDR)
Ref SPA825RNA
Identity
- Trade Name
- Spring Operated Hand 8 1/4 Right - 1/2 X 20 Tpi EUDAMEDSpring Op Hand FDA UDI
- Generic Name
- Body-powered hand prosthesis FDA UDI
- Device Name
- Body-powered hand prosthesis EUDAMED
- Model / Reference
- SPA825RNA EUDAMEDSpring Operated Hand 8 1/4 Right - 1/2 X 20 Tpi FDA UDI
Identifiers
- Catalog Number
- SPA825RNA FDA UDI
- Primary DI / UDI-DI
- 50563495607482 EUDAMED05056349560748 FDA UDI
- Basic UDI-DI
- 50553482MEH0008P EUDAMED
- FDA Product Code
- IRA FDA UDI
- EMDN Code
- Y061899 UPPER EXTREMITY PROSTHESES - OTHER EUDAMED
- GMDN Term
- Body-powered 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
Spring Operated Hand 8 1/4 Right - 1/2 X 20 Tpi by Hugh Steeper Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 50553482MEH0008P | 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 66d5f521-7813-4663-bd4f-b11e796ecc3c 61 fields · synced Jul 14, 2026
- FDA UDI 96fe80d3-4e34-41d1-8028-86c03ea60387 33 fields · synced May 25, 2026