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TrueFinish ™ PVC Glove Number# Colour#

EUDAMED

Class I (EU MDR)

Ref TG85/E9Ref TG79/E4

by Hugh Steeper Limited

Identity

Trade Name
TrueFinish ™ PVC Glove Number# Colour# EUDAMED
Device Name
External limb prosthesis finishing component, non-customized EUDAMED
PVC Glove EUDAMED
Model / Reference
TG85/E9 EUDAMED
TG79/E4 EUDAMED

Identifiers

Primary DI / UDI-DI
50563495743012 EUDAMED
05056349572789 EUDAMED
Basic UDI-DI
50553482COS000AG EUDAMED
50553482PVCWG EUDAMED
EMDN Code
Y061899,Y062499 EUDAMED
Y090312 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 ™ PVC Glove 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

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Manufacturer

EUDAMED SRN
GB-MF-000010196
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (2)

  • EUDAMED 4906de39-1a0c-4562-af9b-6b3361b5066c 61 fields · synced Sep 30, 2026
  • EUDAMED 7ead5dc6-08e4-490c-9194-6f76e536f2e3 61 fields · synced Sep 30, 2026