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SeleneView® HO35

by MacroLux Medical Technology Co., Ltd.

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

Ref HO35Model HC29/ HC29-G/ HC35/ HC35-G/ HO35/ HO35-G/ HO42/ HO42-G

SeleneView® HO35 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), cleared under FDA 510(k) K240978 on 16 Aug 2024 and listed in FDA GUDID since 23 Aug 2024 (UDI-DI 06975339623203), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K240978

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697533962005MS Basic UDI-DI 06975339623203UDI-DIDate29 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06975339623203 UDI-DI Date23 Aug 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK240978 Date16 Aug 2024DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 697533962005MS registered 29 Oct 2025 Active
  • FDA 510(k) K240978 decided 16 Aug 2024 Active
  • FDA GUDID UDI-DI 06975339623203 listed 23 Aug 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K240978
  2. Listed FDA GUDID 06975339623203
  3. Registered EUDAMED 697533962005MS

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
SeleneView EUDAMED
SeleneView® GUDID
Generic name
Rigid video hysteroscope
Model / reference
HO35, HC29/ HC29-G/ HC35/ HC35-G/ HO35/ HO35-G/ HO42/ HO42-G
Primary DI / UDI-DI
06975339623203
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.

Related devices

Cleared under the same submission (K240978)

and 3 more cleared under K240978

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)