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Infants Foam Filled PVC Glove Infants Right 8” E15
EUDAMEDClass I (EU MDR)
Ref AH45/14/E15Ref AH45/28/E15
Identity
- Trade Name
- Infants Foam Filled PVC Glove Infants Right 8” E15 EUDAMED
- Device Name
- Passive hand prosthesis EUDAMED
- Model / Reference
- AH45/14/E15 EUDAMEDAH45/28/E15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 50553482561026 EUDAMED50553482572466 EUDAMED
- Basic UDI-DI
- 50553482PAH0008J 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
The Infants Foam Filled PVC Glove Infants Right 8" E15 is a specialized medical device designed for infants, providing a safe and comfortable way to manage hand function. This passive hand prosthesis features a unique foam filling material that helps distribute pressure evenly, reducing discomfort and fatigue.
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 | 50553482PAH0008J | 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 (2)
- EUDAMED 876ace14-36a1-466c-8181-1342fffb11a9 61 fields · synced Aug 1, 2026
- EUDAMED e343fc72-b11b-40a3-a467-a55fb8af7489 61 fields · synced May 19, 2026