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CoralView® U20

by MacroLux Medical Technology Co., Ltd.

Ref U20Model U10, U10-B, U10-BR, U20, U20-B, U20-BR

CoralView® U20 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 697533962001MJ), cleared under FDA 510(k) K231774 on 11 Jan 2024 and listed in FDA GUDID since 28 Mar 2024 (UDI-DI 06975339620332), 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) K231774

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 Number697533962001MJ Basic UDI-DI 06975339620332UDI-DIDate29 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06975339620332 UDI-DI Date28 Mar 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK231774 Date11 Jan 2024DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 697533962001MJ registered 29 Oct 2025 Active
  • FDA 510(k) K231774 decided 11 Jan 2024 Active
  • FDA GUDID UDI-DI 06975339620332 listed 28 Mar 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K231774
  2. Listed FDA GUDID 06975339620332
  3. Registered EUDAMED 697533962001MJ

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  • Withdrawn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
CoralView EUDAMED
CoralView® GUDID
Generic name
Flexible video ureteroscope, single-use
Model / reference
U20, U10, U10-B, U10-BR, U20-B, U20-BR
Primary DI / UDI-DI
06975339620332
Basic UDI-DI
697533962001MJ
FDA product code
FGB
EMDN code
Z12020713 Ureterorenoscopes
GMDN term
Flexible video ureteroscope, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1500
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

Category: Flexible video ureteroscope, single-use

Cleared under the same submission (K231774)

Similar devices in this category

Other devices filed under URETERORENOSCOPES.

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)