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mini-f

by HEINE Optotechnik GmbH & Co. KG

Ref D-008.73.110

mini-f (D-008.73.110) is a Class I device made by Heine Optotechnik GmbH & Co. KG, registered in EUDAMED on 28 Sep 2026 (Basic UDI-DI 4053755_HHEL_03_MS) and listed in FDA GUDID since 3 Sep 2026 (UDI-DI 04053755214013), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4053755_HHEL_03_MS Basic UDI-DI 04053755214013UDI-DIDate28 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04053755214013 UDI-DI Date3 Sep 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4053755_HHEL_03_MS registered 28 Sep 2026 Active
  • FDA GUDID UDI-DI 04053755214013 listed 3 Sep 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04053755214013
  2. Registered EUDAMED 4053755_HHEL_03_MS

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  • Withdrawn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

Generic name
Hand-held examination/treatment light
Model / Ref / Catalog
D-008.73.110, 000
Primary DI / UDI-DI
04053755214013 EUDAMED
04053755214037 GUDID
Basic UDI-DI
4053755_HHEL_03_MS
Direct marketing DI
04053755214013
FDA product code
KYT
EMDN code
Z129004 Light sources
GMDN term
Hand-held examination/treatment light
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 · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
D-008.73.110
GUDID
000
Primary DI / UDI-DIEUDAMED
04053755214013
GUDID
04053755214037

The registries describe this device under different primary UDI-DIs (EUDAMED lists 04053755214013; FDA GUDID lists 04053755214037), so their flags are not compared.

Manufacturer details

EUDAMED SRN
DE-MF-000006269

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Properties

  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)