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Medtecs CoverU Disposable Isolation Gown

EUDAMED

Class I (EU MDR)

Ref IL-4063WKTPRef IL-4063WKRef IL-4036YKTPRef IL-4036YK

by Medtecs (Cambodia) Corp, Ltd.

Identity

Trade Name
Medtecs CoverU Disposable Isolation Gown EUDAMED
Device Name
Disposable Isolation Gown EUDAMED
Model / Reference
IL-4063WKTP EUDAMED
IL-4063WK EUDAMED
IL-4036YKTP EUDAMED
IL-4036YK EUDAMED

Identifiers

Primary DI / UDI-DI
04710415362315 EUDAMED
04710415362308 EUDAMED
04710415362285 EUDAMED
04710415362278 EUDAMED
Basic UDI-DI
471041536IL0148 EUDAMED
EMDN Code
T0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Netherlands 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

Medtecs CoverU Disposable Isolation Gown by Medtecs (Cambodia) Corp, Ltd. — 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
Medtecs (Cambodia) Corp, Ltd.
EUDAMED SRN
KH-MF-000029845
Authorised Representative
Luana Med. B.V. NL-AR-000002750

Sources (4)

  • EUDAMED fb10afaa-4a07-4f85-9248-3127eb046cca 61 fields · synced Jul 21, 2026
  • EUDAMED bf567cd6-a81e-4d0d-b8e5-a6a89ea05049 61 fields · synced May 18, 2026
  • EUDAMED 7de04653-4fcc-408f-ba4e-17fc9e319194 61 fields · synced May 18, 2026
  • EUDAMED fc40238e-c775-4d02-a7c8-991f5d1ea8e5 61 fields · synced Jul 18, 2026