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Infants Foam Filled PVC Glove Infants Right 8” E10
EUDAMEDClass I (EU MDR)
Ref AH45/28/E10
Identity
- Trade Name
- Infants Foam Filled PVC Glove Infants Right 8” E10 EUDAMED
- Device Name
- Passive hand prosthesis EUDAMED
- Model / Reference
- AH45/28/E10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 50553482571926 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” E10 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 (1)
- EUDAMED 8e9c3394-c9bf-4bf0-9f8b-f84b5a7549e1 61 fields · synced Jun 17, 2026