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Infants Foam Filled PVC Glove Infants Left 8” E14
EUDAMEDClass I (EU MDR)
Ref AH45/13/E14Ref AH45/27/E14
Identity
- Trade Name
- Infants Foam Filled PVC Glove Infants Left 8” E14 EUDAMED
- Device Name
- Passive hand prosthesis EUDAMED
- Model / Reference
- AH45/13/E14 EUDAMEDAH45/27/E14 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 50553482559146 EUDAMED50553482570486 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
Infants Foam Filled PVC Glove Infants Left 8” E14 by Hugh Steeper Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 46a0c2d7-e47a-44a5-aa32-61038d80ee3b 61 fields · synced Jul 17, 2026
- EUDAMED 60f7e13e-5546-47d8-a408-4530617c3971 61 fields · synced May 18, 2026