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Delta X Cpp 00

by Heine Optotechnik GmbH & Co. KG

Ref K-000.34.237Model DELTA X

Delta X Cpp 00 (K-000.34.237) is a Class I device made by Heine Optotechnik GmbH & Co. KG, registered in EUDAMED on 1 Oct 2026 (Basic UDI-DI 4053755_D-A_07_SA) and listed in FDA GUDID since 3 Dec 2025 (UDI-DI 04053755203321), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4053755_D-A_07_SA Basic UDI-DI 04053755203321UDI-DIDate1 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04053755203321 UDI-DI Date3 Dec 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4053755_D-A_07_SA registered 1 Oct 2026 Active
  • FDA GUDID UDI-DI 04053755203321 listed 3 Dec 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04053755203321
  2. Registered EUDAMED 4053755_D-A_07_SA

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Delta X Cpp
Generic name
Dermatoscope, optical
Model / Ref / Catalog
DELTA X, K-000.34.237, 00
Primary DI / UDI-DI
04053755203321
Basic UDI-DI
4053755_D-A_07_SA
FDA product code
KYT
EMDN code
Z12040108 Dermatoscopes
GMDN term
Dermatoscope, optical
Device class
Class I
Regulation number
880.6350
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
Model / referenceEUDAMED
DELTA X
K-000.34.237
GUDID
00

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Properties

  • Premarket exempt
Other properties (24, all answered No)