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TrueFinish ™ Silicone Glove Male Number# Colour#
EUDAMEDClass I (EU MDR)
Ref TSG1/E0Ref SG37/E1
Identity
- Trade Name
- TrueFinish ™ Silicone Glove Male Number# Colour# EUDAMEDSilicone Glove Number# Colour# EUDAMED
- Device Name
- External limb prosthesis finishing component, non-customized EUDAMEDSilicone Glove EUDAMED
- Model / Reference
- TSG1/E0 EUDAMEDSG37/E1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 50563495764116 EUDAMED05056349551579 EUDAMED
- Basic UDI-DI
- 50553482COS000AG EUDAMED50553482SILWA EUDAMED
- EMDN Code
- Y061899 UPPER EXTREMITY PROSTHESES - OTHER EUDAMEDY090312 GLOVES AND HANDLES FOR PROSTHESES 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
TrueFinish ™ Silicone Glove Male Number# Colour# 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 | 50553482COS000AG | 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 905de4f1-98af-44dc-aa30-5c029d0e3c4b 61 fields · synced Sep 30, 2026
- EUDAMED 97693dfc-4919-47cb-aa4b-0e0b5ca22430 61 fields · synced Sep 30, 2026