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Cosmetic Hand Right Unisex Child 8 -12 Yrs.
EUDAMEDFDA UDIClass I (EU MDR)
Ref B11076Ref B11080
Identity
- Trade Name
- Cosmetic Hand Right Unisex Child 8 -12 Yrs. EUDAMEDCosmetic Hand Right Unisex Child 5 -8 Yrs. EUDAMEDCOSMETIC HAND FDA UDI
- Generic Name
- Passive hand prosthesis FDA UDI
- Device Name
- Passive hand prosthesis EUDAMED
- Model / Reference
- B11076 EUDAMEDB11080 EUDAMEDCosmetic Hand Right Unisex Child 5 -8 Yrs. FDA UDI
Identifiers
- Catalog Number
- B11080 FDA UDI
- Primary DI / UDI-DI
- 50553482604204 EUDAMED50553482443766 EUDAMED05055348244376 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 Unisex Child 8 -12 Yrs. 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 | 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 61d5c03f-1e8f-43e8-b30e-4b50a402acc4 61 fields · synced Aug 3, 2026
- EUDAMED a5d4009b-6f6f-4ea0-9a70-d8d7c750d72d 61 fields · synced May 18, 2026
- FDA UDI 3332a001-e205-4218-b1a3-1aa2ba1d619d 33 fields · synced May 30, 2026