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LensHooke Sperm Separation Device CA0 Package-150 sets-US-BR

by Bonraybio Co., Ltd.

LensHooke Sperm Separation Device CA0 Package-150 sets-US-BR is a sperm filtration system (FDA Class II; FDA product code MQK, Labware, Assisted Reproduction) made by Bonraybio Co., Ltd., cleared under FDA 510(k) K221810 on 31 Oct 2022, registered in EUDAMED and listed in FDA GUDID since 16 Feb 2025 (UDI-DI 24719874742250), active as of 23 Oct 2026.

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

CE MDR CE IVDD 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) K221810

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number24719874742250 UDI-DI Date16 Feb 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK221810 Date31 Oct 2022IssuedStatusActive
European UnionCE/IVDD EUDAMED Number— Date—StatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K221810 decided 31 Oct 2022 Active
  • EUDAMED Active· +1 more in the status table
  • FDA GUDID UDI-DI 24719874742250 listed 16 Feb 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K221810
  2. Listed FDA GUDID 24719874742250

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
LensHooke Sperm Separation Device
Generic name
Sperm filtration system
Model / Ref / Catalog
CA0 Package-150 sets-US-BR, CA0
Primary DI / UDI-DI
24719874742250
510(k) Number
FDA product code
MQK
GMDN term
Sperm filtration system
Device class
Class II
Regulation number
884.6160
GUDID distribution status
In Commercial Distribution

Related devices

Category: Sperm filtration system

Cleared under the same submission (K221810)

and 4 more cleared under K221810

Similar devices

Other devices filed under FDA product code MQK (Labware, Assisted Reproduction).

Other devices from Bonraybio Co., Ltd.

See all devices from Bonraybio Co., Ltd. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)