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Sterile Surgical Packs

EUDAMED

Class I (EU MDR)

Ref 70-1003-SModel Universal Set Reinforced; Universal Slit Sheet Set; Minor Surgery Set Up Set; Minor Surgery Set; Craniotomy Drape Set; Laparotomy/Chest Set; Laparotomy/Chest Pack; Rectum Set; Universal Self-Adhesive Reinforced Set; Angiography Set; CABG Pack; etc.

by Kenpax International Limited

Identity

Trade Name
Sterile Surgical Packs EUDAMED
Device Name
Sterile Surgical Packs EUDAMED
Model / Reference
Universal Set Reinforced; Universal Slit Sheet Set; Minor Surgery Set Up Set; Minor Surgery Set; Craniotomy Drape Set; Laparotomy/Chest Set; Laparotomy/Chest Pack; Rectum Set; Universal Self-Adhesive Reinforced Set; Angiography Set; CABG Pack; etc. EUDAMED
70-1003-S EUDAMED

Identifiers

Primary DI / UDI-DI
04895237164054 EUDAMED
Basic UDI-DI
48952371004UX EUDAMED
EMDN Code
T0202 SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) 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 Surgical Packs 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 (1)

  • EUDAMED 9a3ff810-2931-49da-8a13-ac3a299c42d8 61 fields · synced Jun 18, 2026