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Diazyme DZ072B-CON

by Diazyme Laboratories, Inc.

Ref DZ072B-CON

Diazyme DZ072B-CON is a Class B device made by Diazyme Laboratories, Inc., registered in EUDAMED on 25 Sep 2026 (Basic UDI-DI 0817089020085WU) and listed in FDA GUDID since 3 Nov 2016 (UDI-DI 00817089020085), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0817089020085WU Basic UDI-DI 00817089020085UDI-DIDate25 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00817089020085 UDI-DI Date3 Nov 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0817089020085WU registered 25 Sep 2026 Active
  • FDA GUDID UDI-DI 00817089020085 listed 3 Nov 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00817089020085
  2. Registered EUDAMED 0817089020085WU

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Diazyme Creatinine Control Set EUDAMED
Diazyme GUDID
Generic name
Creatinine IVD, control
Device name
Diazyme Creatinine Control
Model / reference
DZ072B-CON
Primary DI / UDI-DI
00817089020085
Basic UDI-DI
0817089020085WU
EMDN code
W0101050299 Specific controls (cc) - other
GMDN term
Creatinine IVD, control
Device class
Class B
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: Creatinine IVD, control

Similar devices in this category

Other devices filed under SPECIFIC CONTROLS (CC) - OTHER.

Other devices from Diazyme Laboratories, Inc.

See all devices from Diazyme Laboratories, Inc. →

Properties

  • Professional testing
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (22, all answered No)