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Pure

by Akzenta International SA 7 variants

Part of a family of 92 devices: see the family page

Ref 735052

Pure (735052) is a Class I device made by Akzenta International SA, registered in EUDAMED on 4 May 2026 (Basic UDI-DI 42504766GLOUP), active as of 23 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number42504766GLOUP Basic UDI-DI 04250476642617UDI-DIDate4 May 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Gloves
Model / reference
735052
Primary DI / UDI-DI
04250476642617
Basic UDI-DI
42504766GLOUP
EMDN code
T01020204 Nitrile examination / treatment gloves
Device class
Class I
EU registration type
Standard device
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CH-MF-000036434
Authorised representative
IQX GmbH AT-AR-000016713

Similar devices in this category

Other devices filed under NITRILE EXAMINATION / TREATMENT GLOVES.

Other devices from Akzenta International SA

See all devices from Akzenta International SA →

Properties

Other properties (14, all answered No)