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Sample buffer (IFA) ZF 1020-0530-R

by EUROIMMUN Medizinische Labordiagnostika AG

Ref ZF 1020-0530-RModel ZF 1020-R

Sample buffer (IFA) ZF 1020-0530-R is a buffered sample diluent IVD (EU IVDR Class A; FDA Class I; FDA product code PPM, General Purpose Reagent) made by EUROIMMUN Medizinische Labordiagnostika AG, registered in EUDAMED on 9 Oct 2026 (Basic UDI-DI 4049016ZF1020RCP) and listed in FDA GUDID since 26 Feb 2025 (UDI-DI 04049016151906), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number4049016ZF1020RCP Basic UDI-DI 04049016151906UDI-DIDate9 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049016151906 UDI-DI Date26 Feb 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4049016ZF1020RCP registered 9 Oct 2026 Active
  • FDA GUDID UDI-DI 04049016151906 listed 26 Feb 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 04049016151906
  2. Registered EUDAMED 4049016ZF1020RCP

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  • Withdrawn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
Sample buffer (IIFT) EUDAMED
Sample buffer (IFA) GUDID
Generic name
Buffered sample diluent IVD
Model / reference
ZF 1020-0530-R, ZF 1020-R
Primary DI / UDI-DI
04049016151906
Basic UDI-DI
4049016ZF1020RCP
FDA product code
PPM
EMDN code
W05039080 Devices for samples analyses - other accessories
GMDN term
Buffered sample diluent 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: Buffered sample diluent IVD

Similar devices in this category

Other devices filed under DEVICES FOR SAMPLES ANALYSES - OTHER ACCESSORIES.

Other devices from EUROIMMUN Medizinische Labordiagnostika AG

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Properties

  • Single use
  • Contains animal tissues or cells
  • Reagent
  • Professional testing
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)