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ELISA Stop solution ZE 1210-1012

by EUROIMMUN Medizinische Labordiagnostika AG

Ref ZE 1210-1012Model ZE 1210

ELISA Stop solution ZE 1210-1012 is a device classified as Class A in the EU and Class I in the US made by EUROIMMUN Medizinische Labordiagnostika AG, registered in EUDAMED on 9 Oct 2026 (Basic UDI-DI 4049016ZE1210G7) and listed in FDA GUDID since 26 Jun 2025 (UDI-DI 04049016151845), active as of 25 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number4049016ZE1210G7 Basic UDI-DI 04049016151845UDI-DIDate9 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049016151845 UDI-DI Date26 Jun 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4049016ZE1210G7 registered 9 Oct 2026 Active
  • FDA GUDID UDI-DI 04049016151845 listed 26 Jun 2025 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

2 dated events

  1. Listed FDA GUDID 04049016151845
  2. Registered EUDAMED 4049016ZE1210G7

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  • Withdrawn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
ELISA Stop solution
Generic name
Sulphuric acid stop solution reagent IVD
Model / reference
ZE 1210-1012, ZE 1210
Primary DI / UDI-DI
04049016151845
Basic UDI-DI
4049016ZE1210G7
FDA product code
PPM
EMDN code
W01029099 Immunochemistry reagents - other
GMDN term
Sulphuric acid stop solution reagent IVD
Device class
Class A EUDAMED
Class I GUDID
Regulation number
864.4010
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class A
GUDID
Class I

Device class is stated on each registry's own scale: Class A in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Sulphuric acid stop solution reagent IVD

Similar devices in this category

Other devices filed under IMMUNOCHEMISTRY REAGENTS - OTHER.

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Properties

  • Single use
  • Professional testing
  • IVD instrument
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)