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Dewax Solution

by Shenzhen Dartmon Biotechnology Co., Ltd.

Ref DMRE3047

Dewax Solution (DMRE3047) is a Class A device made by Shenzhen Dartmon Biotechnology Co., Ltd., registered in EUDAMED on 23 Jun 2026 (Basic UDI-DI 697550352DMRE3047XP), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697550352DMRE3047XP 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  • Withdrawn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
DMRE3047
Primary DI / UDI-DI
06927210903904, 06927210903911, 06975503520475
Basic UDI-DI
697550352DMRE3047XP
Direct marketing DI
06927210903904
06927210903911
06975503520475
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

  • Reagent
  • Professional testing
  • New device
Other properties (10, all answered No)