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Pure

EUDAMED

Class I (EU MDR)

Ref 733408Ref 733404Ref 733400Ref 733412Ref 231787

by Akzenta International SA

Identity

Trade Name
PURE EUDAMED
Device Name
FACE MASKS EUDAMED
GLOVES EUDAMED
Model / Reference
733408 EUDAMED
733404 EUDAMED
733400 EUDAMED
733412 EUDAMED
231787 EUDAMED

Identifiers

Primary DI / UDI-DI
04250476624958 EUDAMED
04250476624361 EUDAMED
04250476624385 EUDAMED
04250476624408 EUDAMED
04250476646066 EUDAMED
Basic UDI-DI
42504766FAMTD EUDAMED
42504766GLOUP EUDAMED
EMDN Code
T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
T01020204 NITRILE EXAMINATION / TREATMENT GLOVES 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

Pure by Akzenta International SA — 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
Akzenta International SA
EUDAMED SRN
CH-MF-000036434
Authorised Representative
IQX GmbH AT-AR-000016713

Sources (5)

  • EUDAMED 878fc7b4-6146-4b52-ad82-2027859e6803 61 fields · synced Oct 6, 2026
  • EUDAMED 332ce6c9-562f-447b-8935-d56504d6a1f4 61 fields · synced May 16, 2026
  • EUDAMED 843d25bc-e427-4d98-801a-303c2683cda6 61 fields · synced May 17, 2026
  • EUDAMED e651b8df-400d-4939-a460-15913399f31e 61 fields · synced May 18, 2026
  • EUDAMED ac6a401d-3a84-45a8-a90f-224b9006bef7 61 fields · synced Jul 26, 2026