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Immunohistochemical Antigen Retrieval Buffer

by Shenzhen Dartmon Biotechnology Co., Ltd. 2 variants

Ref DMRD2048

Immunohistochemical Antigen Retrieval Buffer (DMRD2048) is a Class A device made by Shenzhen Dartmon Biotechnology Co., Ltd., registered in EUDAMED on 23 Jun 2026 (Basic UDI-DI 697550352DMRD2048X7), active as of 24 Oct 2026.

Active European Union

CE IVDR

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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697550352DMRD2048X7 Basic UDI-DI Date23 Jun 2026RegisteredStatusActive

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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Model / reference
DMRD2048
Primary DI / UDI-DI
06975503520482, 06927210903928
Basic UDI-DI
697550352DMRD2048X7
Direct marketing DI
06975503520482
06927210903928
EMDN code
W01030799 Histology / cytology reagents - other
Device class
Class A
EU registration type
Standard device
EU market of registration
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000019183
Authorised representative
Umedwings Netherlands B.V. NL-AR-000000444

Similar devices in this category

Other devices filed under HISTOLOGY / CYTOLOGY REAGENTS - OTHER.

Other devices from Shenzhen Dartmon Biotechnology Co., Ltd.

See all devices from Shenzhen Dartmon Biotechnology Co., Ltd. →

Properties

  • Contains animal tissues or cells
  • Reagent
  • Professional testing
  • New device
Other properties (9, all answered No)