← Back to catalogue

Sterile Standard Surgical Gowns

EUDAMED

Class I (EU MDR)

Ref 67-5110-SModel Standard Gown; Standard Plus Gown; Performance Plus Gown; Premium Performance Plus Gown; EN Standard S.Gown+1 Towels+CSR M-XXL; EN Standard Surgical Gown+2 Towels+CSR M-XXL; EN Standard Surgical Gown+2 Towels+CSR L-XXL Long; etc.

by Kenpax International Limited

Identity

Trade Name
Sterile Standard Surgical Gowns EUDAMED
Device Name
Sterile Standard Surgical Gowns EUDAMED
Model / Reference
Standard Gown; Standard Plus Gown; Performance Plus Gown; Premium Performance Plus Gown; EN Standard S.Gown+1 Towels+CSR M-XXL; EN Standard Surgical Gown+2 Towels+CSR M-XXL; EN Standard Surgical Gown+2 Towels+CSR L-XXL Long; etc. EUDAMED
67-5110-S EUDAMED

Identifiers

Primary DI / UDI-DI
04895237110495 EUDAMED
Basic UDI-DI
48952371001UR EUDAMED
EMDN Code
T020401 STANDARD SURGICAL GOWNS EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Germany 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

Sterile Standard Surgical Gowns 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

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

Sources (1)

  • EUDAMED 0272ab84-d875-4b7d-a17c-1e229db44900 61 fields · synced Jun 18, 2026