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Erg (QR040)

by biocyc Biotechnologie GmbH & Co. KG 6 variants

Ref C-E003-025, C-E003-05

Erg (QR040) (C-E003-025) is a device classified as IVD General made by biocyc Biotechnologie GmbH & Co. KG, registered in EUDAMED on 16 Oct 2023 (Basic UDI-DI B-C-E003-025HJ), active as of 7 Nov 2026.

Active European Union

CE IVDD

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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-C-E003-025HJ Basic UDI-DI Date16 Oct 2023RegisteredStatusActive

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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Model / reference
C-E003-025, C-E003-05
Primary DI / UDI-DI
D-C-E003-025HJ, D-C-E003-05Z2
Basic UDI-DI
B-C-E003-025HJ, B-C-E003-05Z2
EMDN code
W01030709 Primary antisera for immunohistology
Device class
Class IVD General
EU registration type
Legacy device (under a directive)
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000031533

Similar devices in this category

Other devices filed under PRIMARY ANTISERA FOR IMMUNOHISTOLOGY.

Other devices from biocyc Biotechnologie GmbH & Co. KG

See all devices from biocyc Biotechnologie GmbH & Co. KG →

Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Reagent
  • Professional testing
Other properties (8, all answered No)