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Sterile Reinforced Surgical Gowns

EUDAMED

Class I (EU MDR)

Ref 65-9650-SModel Poly Reinforced Gown; Performance Plus (Reinforced) Gown; EN High Surgical Gown+1 Towels+CSR M-4XL; EN High Surgical Gown+2 Towels+CSR M-4XLRef 67-9153-SRef 65-A120-SRef 67-9141-SRef 65-A110-SRef 65-9640-SRef 67-3128-SRef 65-A135-SRef 65-A130-SRef 67-9123-SRef 65-A140-SRef 65-9630-SRef 65-9135-SRef 65-9110-SRef 67-3320-SRef 67-3138-SRef 65-9660-SRef 67-9133-SRef 65-9120-SRef 65-A150-SRef 67-3130-SRef 65-9620-SRef 67-9161-SRef 67-9143-SRef 67-9113-SRef 65-9130-S

by Kenpax International Limited

Identity

Trade Name
Sterile Reinforced Surgical Gowns EUDAMED
Device Name
Sterile Reinforced Surgical Gowns EUDAMED
Model / Reference
Poly Reinforced Gown; Performance Plus (Reinforced) Gown; EN High Surgical Gown+1 Towels+CSR M-4XL; EN High Surgical Gown+2 Towels+CSR M-4XL EUDAMED
65-9650-S EUDAMED
67-9153-S EUDAMED
65-A120-S EUDAMED
67-9141-S EUDAMED
65-A110-S EUDAMED
65-9640-S EUDAMED
67-3128-S EUDAMED
65-A135-S EUDAMED
65-A130-S EUDAMED
67-9123-S EUDAMED
65-A140-S EUDAMED
65-9630-S EUDAMED
65-9135-S EUDAMED
65-9110-S EUDAMED
67-3320-S EUDAMED
67-3138-S EUDAMED
65-9660-S EUDAMED
67-9133-S EUDAMED
65-9120-S EUDAMED
65-A150-S EUDAMED
67-3130-S EUDAMED
65-9620-S EUDAMED
67-9161-S EUDAMED
67-9143-S EUDAMED
67-9113-S EUDAMED
65-9130-S EUDAMED

Identifiers

Primary DI / UDI-DI
04895237110402 EUDAMED
04895237110280 EUDAMED
04895237107839 EUDAMED
04895237110211 EUDAMED
04895237107822 EUDAMED
04895237110396 EUDAMED
04895237110679 EUDAMED
04895237107884 EUDAMED
04895237107846 EUDAMED
04895237110259 EUDAMED
04895237107853 EUDAMED
04895237110389 EUDAMED
04895237110167 EUDAMED
04895237110112 EUDAMED
74895237110708 EUDAMED
04895237107242 EUDAMED
04895237110419 EUDAMED
04895237110266 EUDAMED
04895237110129 EUDAMED
04895237107860 EUDAMED
04895237110648 EUDAMED
04895237110372 EUDAMED
04895237110235 EUDAMED
04895237110273 EUDAMED
04895237110242 EUDAMED
04895237110136 EUDAMED
Basic UDI-DI
48952371002UT EUDAMED
EMDN Code
T020402 REINFORCED 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 Reinforced 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 (26)

  • EUDAMED 9246724c-245d-44ae-ad18-6de27751e287 61 fields · synced Sep 17, 2026
  • EUDAMED a1d1a434-877e-4eda-9554-518473b1a4b4 61 fields · synced May 17, 2026
  • EUDAMED bddc0db9-e801-42f7-b42b-12e516d6474d 61 fields · synced May 17, 2026
  • EUDAMED db42e652-35a8-4d17-922e-3da95cba3041 61 fields · synced May 17, 2026
  • EUDAMED 31533d7a-7a4d-4785-87ea-3fae595bce99 61 fields · synced May 17, 2026
  • EUDAMED 20433c60-ed73-4f07-9a89-3f78c853678f 61 fields · synced May 17, 2026
  • EUDAMED 83be071b-33ed-4edf-9fed-86b08b3d2ebd 61 fields · synced May 17, 2026
  • EUDAMED 1442a08d-6902-4744-8f25-8fe7c3185861 61 fields · synced May 17, 2026
  • EUDAMED a6c4dbc2-36c2-47d8-b04d-f2f13d3126a1 61 fields · synced May 17, 2026
  • EUDAMED 3eecd904-f9f9-444e-a96e-92822ac715d0 61 fields · synced May 17, 2026
  • EUDAMED 106defea-2452-461d-a60f-a6ea26a12c39 61 fields · synced May 17, 2026
  • EUDAMED a8899411-eb73-40d2-83d9-7b140bec0a1a 61 fields · synced May 17, 2026
  • EUDAMED a351cd08-49d4-4457-a900-1259b0ccebb4 61 fields · synced May 17, 2026
  • EUDAMED e6e2fc05-32b1-420c-b004-d1604187016a 61 fields · synced May 17, 2026
  • EUDAMED 28b4c3fb-528b-45b3-b36c-f9a6b81509a9 61 fields · synced May 17, 2026
  • EUDAMED ca52dda7-527d-42d4-9594-cf482d3b8d9f 61 fields · synced May 17, 2026
  • EUDAMED f97ac9e4-5c0a-4efe-82d8-93a068689382 61 fields · synced May 18, 2026
  • EUDAMED b09e2c18-beb9-448e-8158-ebe4d1b3651c 61 fields · synced May 18, 2026
  • EUDAMED 90aed776-d8b8-46dc-a9b8-170548be760c 61 fields · synced May 18, 2026
  • EUDAMED 86bbad18-1f07-4390-b3ed-3445e67744de 61 fields · synced May 18, 2026
  • EUDAMED 80467670-d0f3-4bbc-a961-f2a360efdac8 61 fields · synced May 18, 2026
  • EUDAMED ae241dc2-5ed0-4c08-85f5-b89509c0670a 61 fields · synced May 18, 2026
  • EUDAMED 08ee1f72-3988-40a1-b326-dd33edd159b9 61 fields · synced May 18, 2026
  • EUDAMED c341dfe5-db39-4181-957d-c9d547a5345a 61 fields · synced May 18, 2026
  • EUDAMED 057711ce-032c-47e6-858c-480682b14ea6 61 fields · synced May 19, 2026
  • EUDAMED 220fcf90-ce32-40a2-ba58-3608f97b6336 61 fields · synced May 19, 2026