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Infants Foam Filled PVC Glove Infants Right 8” E13
EUDAMEDClass I (EU MDR)
Ref AH45/14/E13Ref AH45/28/E13
Identity
- Trade Name
- Infants Foam Filled PVC Glove Infants Right 8” E13 EUDAMED
- Device Name
- Passive hand prosthesis EUDAMED
- Model / Reference
- AH45/14/E13 EUDAMEDAH45/28/E13 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 50553482560890 EUDAMED50553482572220 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 Right 8” E13 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 4c1cf040-6e05-4dda-8aee-7091e32be270 61 fields · synced Jul 8, 2026
- EUDAMED bced0822-60ec-4baa-85db-def2302a312b 61 fields · synced May 18, 2026