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Sterile Standard Surgical Gowns

EUDAMED

Class I (EU MDR)

Ref 67-2110-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.Ref 67-5140-SRef 67-5138-SRef 65-7135-SRef 65-7110-SRef 65-7640-SRef 65-7630-SRef 65-7120-SRef 67-5130-SRef 67-1138-SRef 67-1118-SRef 67-5330-SRef 65-7650-SRef 67-5320-SRef 67-5128-SRef 67-5120-SRef 67-5118-SRef 67-1110-SRef 65-7610-SRef 67-2120-SRef 67-2122-SRef 65-7620-SRef 67-2130-SRef 67-1128-SRef 67-5148-S

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
67-2110-S EUDAMED
67-5140-S EUDAMED
67-5138-S EUDAMED
65-7135-S EUDAMED
65-7110-S EUDAMED
65-7640-S EUDAMED
65-7630-S EUDAMED
65-7120-S EUDAMED
67-5130-S EUDAMED
67-1138-S EUDAMED
67-1118-S EUDAMED
67-5330-S EUDAMED
65-7650-S EUDAMED
67-5320-S EUDAMED
67-5128-S EUDAMED
67-5120-S EUDAMED
67-5118-S EUDAMED
67-1110-S EUDAMED
65-7610-S EUDAMED
67-2120-S EUDAMED
67-2122-S EUDAMED
65-7620-S EUDAMED
67-2130-S EUDAMED
67-1128-S EUDAMED
67-5148-S EUDAMED

Identifiers

Primary DI / UDI-DI
04895237110082 EUDAMED
04895237110525 EUDAMED
04895237110556 EUDAMED
04895237110068 EUDAMED
04895237110013 EUDAMED
04895237110334 EUDAMED
04895237110327 EUDAMED
04895237110020 EUDAMED
04895237110518 EUDAMED
04895237110471 EUDAMED
04895237110457 EUDAMED
74895237110753 EUDAMED
04895237110341 EUDAMED
74895237107258 EUDAMED
04895237110549 EUDAMED
04895237110501 EUDAMED
04895237110532 EUDAMED
04895237110426 EUDAMED
04895237110303 EUDAMED
04895237110099 EUDAMED
04895237110594 EUDAMED
04895237110310 EUDAMED
04895237110105 EUDAMED
04895237110464 EUDAMED
04895237110563 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

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Manufacturer

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

Sources (25)

  • EUDAMED d0871f3f-37ac-45e6-b566-31a21c6f439d 61 fields · synced Aug 4, 2026
  • EUDAMED d59450d6-8578-47fd-aff6-94814059b1b4 61 fields · synced May 11, 2026
  • EUDAMED e1316358-2e64-48ee-9c0d-f550236b3b30 61 fields · synced May 16, 2026
  • EUDAMED 72a17661-d928-46e4-992e-60c57e146f4f 61 fields · synced May 16, 2026
  • EUDAMED 8b99603f-5335-4e03-93d5-cd9011953250 61 fields · synced May 16, 2026
  • EUDAMED 833a52dc-2899-4af1-8a08-54330266bf43 61 fields · synced May 17, 2026
  • EUDAMED 16863fdb-fde7-4494-b7ee-54f6cfb5af87 61 fields · synced May 17, 2026
  • EUDAMED cf5f4ad4-99ac-460e-8ead-4d33dde9a5ec 61 fields · synced May 17, 2026
  • EUDAMED 0dc1a2ea-260f-4449-98cf-e293dd3ad494 61 fields · synced May 17, 2026
  • EUDAMED b5b41426-c200-49ca-a34d-cf11904b865c 61 fields · synced May 17, 2026
  • EUDAMED 30f97a29-73b4-4e0b-a50f-d5e8b3b709dd 61 fields · synced May 17, 2026
  • EUDAMED f64456c1-3b52-45a5-995f-088fa045e2cb 61 fields · synced May 17, 2026
  • EUDAMED 0796db1e-79eb-4ebd-b657-1115826bd1b1 61 fields · synced May 17, 2026
  • EUDAMED b81caae8-f5a0-4d32-89ea-f58e93508063 61 fields · synced May 17, 2026
  • EUDAMED 57d05780-acb5-454f-a472-38e9bf8a7cd5 61 fields · synced May 17, 2026
  • EUDAMED cec54c6a-7145-47d6-9660-f81ecff8e42b 61 fields · synced May 17, 2026
  • EUDAMED 98383e12-b307-44cc-a366-b93437c26aed 61 fields · synced May 18, 2026
  • EUDAMED 6ce88255-120c-4c9a-b2ef-8bbc31742790 61 fields · synced May 18, 2026
  • EUDAMED ec170e8e-c698-4c63-8cf3-7fb3eedabaa9 61 fields · synced May 18, 2026
  • EUDAMED 8eb31aa3-e7b5-4095-897e-744ec1756b3e 61 fields · synced May 18, 2026
  • EUDAMED 1499b769-b00b-4458-8807-0a57a8c4b147 61 fields · synced May 18, 2026
  • EUDAMED ad6b2f8b-fc13-43fc-b18f-b08c41e77a78 61 fields · synced May 18, 2026
  • EUDAMED a333a928-784a-498f-93b9-1901db8d3b5c 61 fields · synced May 18, 2026
  • EUDAMED a57d2f9c-1787-40a6-afef-653368bc0e4e 61 fields · synced May 18, 2026
  • EUDAMED 84dbdfbb-8192-4226-b2d9-b6a54c2b3712 61 fields · synced May 19, 2026