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Nitrile TEXTURDE SURFACE S

EUDAMED

Class I (EU MDR)

Ref E12SModel Model: Nitrile Specification：TEXTURDE SURFACE, SMOOTH SURFACE,POWDERED SURFACE, POWDER-FREE SURFACE. Size: XS, S, M, L, XL

by Jiangxi Hongda Medical Equipment Group Ltd.

Identity

Trade Name
Nitrile TEXTURDE SURFACE S EUDAMED
Device Name
Single-use medical examination gloves EUDAMED
Model / Reference
Model: Nitrile Specification：TEXTURDE SURFACE, SMOOTH SURFACE,POWDERED SURFACE, POWDER-FREE SURFACE. Size: XS, S, M, L, XL EUDAMED
E12S EUDAMED

Identifiers

Primary DI / UDI-DI
66920756725650 EUDAMED
Basic UDI-DI
69207567DJJCST0001YV EUDAMED
EMDN Code
T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Hungary EUDAMED

Clinical & Handling

Sterile

Yes

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

Nitrile TEXTURDE SURFACE S by Jiangxi Hongda Medical Equipment Group Ltd. — 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

Manufacturer
Jiangxi Hongda Medical Equipment Group Ltd.
EUDAMED SRN
CN-MF-000006019
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

  • EUDAMED 9babe70f-cc1f-4ecc-9293-146bfd9a46da 61 fields · synced Oct 8, 2026