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Bio Miratray Sortiment I 50er

by Hager & Werken GmbH & Co. KG

Ref 641149Model 000200

Active European Union

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Overview

For medical professionals, the Bio Miratray Sortiment I 50er device is a valuable tool for accurately measuring insulin dosages. By utilizing advanced technology and precise instrumentation, this device provides reliable results in various clinical settings.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number409963700020038 Basic UDI-DI 04099637006277UDI-DIDate2 Mar 2026RegisteredStatusActive

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  • Withdrawn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
Abformlöffel, einmalige Anwendung
Model / Reference
000200, 641149
Primary DI / UDI-DI
04099637006277
Basic UDI-DI
409963700020038
Unit of Use DI
04099637006260
EMDN Code
Q010503 Impression material trays, single-use
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000004938

Other devices from Hager & Werken GmbH & Co. KG

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Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No