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Cosmetic Hand Right Female Youth/Adult Extended Wires
EUDAMEDFDA UDIClass I (EU MDR)
Ref B11096Ref FHEXL8
Identity
- Trade Name
- Cosmetic Hand Right Female Youth/Adult Extended Wires EUDAMEDCosmetic Hand Right Female/Youth Adult Extended Wires EUDAMEDCOSMETIC HAND FDA UDI
- Generic Name
- Passive hand prosthesis FDA UDI
- Device Name
- Passive hand prosthesis EUDAMED
- Model / Reference
- B11096 EUDAMEDFHEXL8 EUDAMEDCosmetic Hand Right Female/Youth Adult Extended Wires FDA UDI
Identifiers
- Catalog Number
- FHEXL8 FDA UDI
- Primary DI / UDI-DI
- 50553482606420 EUDAMED50553482802136 EUDAMED05055348280213 FDA UDI
- Basic UDI-DI
- 50553482PAH0008J EUDAMED
- FDA Product Code
- IRA FDA UDI
- EMDN Code
- Y061899 UPPER EXTREMITY PROSTHESES - OTHER EUDAMED
- GMDN Term
- Passive 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
Cosmetic Hand Right Female Youth/Adult Extended Wires 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 | 50553482PAH0008J | 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 (3)
- EUDAMED 943d101b-f802-4732-8594-5438794c9ef8 61 fields · synced Oct 6, 2026
- EUDAMED 45e7c35f-9c1c-4447-b665-1ec7c68281a1 61 fields · synced May 18, 2026
- FDA UDI bf825ecb-8a64-42ec-a851-65bd8e5cdebd 33 fields · synced May 30, 2026