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Polyethylene Film Gown

EUDAMED

Class I (EU MDR)

Ref 68-6201-BRef 68-6203-BRef 5210PGRef 5211PGRef 5213PG

by Kenpax International Limited

Identity

Trade Name
Polyethylene Film Gown EUDAMED
Device Name
Polyethylene Film Gown EUDAMED
Model / Reference
68-6201-B EUDAMED
68-6203-B EUDAMED
5210PG EUDAMED
5211PG EUDAMED
5213PG EUDAMED

Identifiers

Primary DI / UDI-DI
74895237108491 EUDAMED
74895237108514 EUDAMED
74895237108460 EUDAMED
74895237108477 EUDAMED
74895237108484 EUDAMED
Basic UDI-DI
48952371T0205JQ EUDAMED
EMDN Code
T0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Germany 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

Polyethylene Film Gown by Kenpax International 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

Manufacturer
Kenpax International Limited
EUDAMED SRN
HK-MF-000021152
Authorised Representative
MedPath GmbH DE-AR-000000087

Sources (5)

  • EUDAMED 23d1160c-6480-4877-bc1a-4c99f100867c 61 fields · synced Aug 3, 2026
  • EUDAMED 4068d5f0-aad0-4ac9-8401-685c34b76526 61 fields · synced May 17, 2026
  • EUDAMED 17073e8e-0749-4733-ad21-07511e26f7b3 61 fields · synced May 18, 2026
  • EUDAMED 4972298f-776e-4ea7-a740-fca7a9a41525 61 fields · synced May 19, 2026
  • EUDAMED 2754203b-9f2e-4d20-86a0-733bab8e2329 61 fields · synced May 19, 2026