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SeleneView

by MacroLux Medical Technology Co., Ltd.

Part of a family of 9 devices: see the family page

Ref HO42Model HC29/ HC29-G/ HC35/ HC35-G/ HO35/ HO35-G/ HO42/ HO42-G

SeleneView (HO42) is a device classified as Class IIa in the EU and Class II in the US made by MacroLux Medical Technology Co., Ltd., registered in EUDAMED on 29 Oct 2025 (Basic UDI-DI 697533962005MS) and listed in FDA GUDID since 3 Jul 2026 (UDI-DI 06975339623418), 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
United StatesGUDID listing GUDID Number06975339623418 UDI-DI Date3 Jul 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697533962005MS Basic UDI-DI 06975339623418UDI-DIDate29 Oct 2025RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 697533962005MS registered 29 Oct 2025 Active
  • FDA GUDID UDI-DI 06975339623418 listed 3 Jul 2026 Listed

Timeline

2 dated events

  1. Registered EUDAMED 697533962005MS
  2. Listed FDA GUDID 06975339623418

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  • Withdrawn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
Rigid video hysteroscope
Model / reference
HC29/ HC29-G/ HC35/ HC35-G/ HO35/ HO35-G/ HO42/ HO42-G, HO42
Primary DI / UDI-DI
06975339623418
Basic UDI-DI
697533962005MS
FDA product code
HIH
EMDN code
Z12020704 Hysteroscopes
GMDN term
Rigid video hysteroscope
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
884.1690
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

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

Manufacturer details

EUDAMED SRN
CN-MF-000025085
Authorised representative
Wellkang Ltd XI-AR-000001836

Similar devices in this category

Other devices filed under HYSTEROSCOPES.

Other devices from MacroLux Medical Technology Co., Ltd.

See all devices from MacroLux Medical Technology Co., Ltd. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)