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ISH Lambda Probe

by Shenzhen Dartmon Biotechnology Co., Ltd.

Ref DMRD0580

ISH Lambda Probe (DMRD0580) is a device classified as IVD General made by Shenzhen Dartmon Biotechnology Co., Ltd., registered in EUDAMED on 29 Jun 2026 (Basic UDI-DI B-06927210914092), active as of 25 Oct 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06927210914092 Basic UDI-DI Date29 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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Model / reference
DMRD0580
Primary DI / UDI-DI
06927210914092, 06927210914078, 06927210914085, 06927210914061
Basic UDI-DI
B-06927210914092, B-06927210914078, B-06927210914085, B-06927210914061
EMDN code
W01030703 DNA in situ hybridisation reagents
Device class
Class IVD General
EU registration type
Legacy device (under a directive)
EU market of registration
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000019183
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Similar devices in this category

Other devices filed under DNA IN SITU HYBRIDISATION REAGENTS.

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
Other properties (10, all answered No)