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Lady-Comp

by Valley Electronics AG

Ref Lady-Comp

Lady-Comp is a fertility analyser (EU MDR Class I; FDA unclassified; FDA product code LHD, Device, Fertility Diagnostic, Proceptive) made by Valley Electronics AG, registered in EUDAMED on 15 Oct 2024 (Basic UDI-DI 7629999ZCPRZ) and listed in FDA GUDID since 7 Dec 2022 (UDI-DI 07629999894334), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7629999ZCPRZ Basic UDI-DI 07629999894334UDI-DIDate15 Oct 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number07629999894334 UDI-DI Date7 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 7629999ZCPRZ registered 15 Oct 2024 Active
  • FDA GUDID UDI-DI 07629999894334 listed 7 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07629999894334
  2. Registered EUDAMED 7629999ZCPRZ

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  • Withdrawn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
Fertility analyser, temperature
Device name
Zcp
Model / reference
Lady-Comp EUDAMED
894334 GUDID
Primary DI / UDI-DI
07629999894334
Basic UDI-DI
7629999ZCPRZ
FDA product code
LHD
EMDN code
U080299 Devices for assisted reproduction - other
GMDN term
Fertility analyser, temperature
Device class
Class I EUDAMED
U GUDID
System or procedure pack
System which is a device in itself
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
Lady-Comp
GUDID
894334
Device classEUDAMED
Class I
GUDID
U

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), U in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
CH-MF-000014362
Authorised representative
M.I.S.S. GmbH DE-AR-000011822

Related devices

Category: Assisted reproduction vitrification carrier

Similar devices in this category

Other devices filed under DEVICES FOR ASSISTED REPRODUCTION - OTHER.

Other devices from Valley Electronics AG

  • Daysy

    Class I

Properties

  • Premarket exempt
  • Lot / batch number
Other properties (23, all answered No)