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CoralWell NS-0835B

by MacroLux Medical Technology Co., Ltd. 2 variants

Part of a family of 44 devices: see the family page

Ref NS-0835BModel NS-0835B,NS-0840B,NS-0845B,NS-0855B,NS-0935B,NS-0940B,NS-0945B,NS-0955B,NS-1035B,NS-1040B,NS-1045B,NS-1055B,NS-1135B,NS-1140B,NS-1145B,NS-1155B,NS-1235B,NS-1240B,NS-1245B,NS-1255B,NS-1335B,NS-1340B,NS-1345B,NS-1355B,NS-1435B,NS-1440B,NS-1445B,NS-1455B

CoralWell NS-0835B 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 697533962006MU), cleared under FDA 510(k) K250452 on 2 Jun 2025 and listed in FDA GUDID since 26 Aug 2025 (UDI-DI 06975339628123), 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) K250452

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 Number697533962006MU Basic UDI-DI 06975339628123UDI-DIDate29 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06975339628123 UDI-DI Date26 Aug 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK250452 Date2 Jun 2025DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 697533962006MU registered 29 Oct 2025 Active
  • FDA 510(k) K250452 decided 2 Jun 2025 Active
  • FDA GUDID UDI-DI 06975339628123 listed 26 Aug 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K250452
  2. Listed FDA GUDID 06975339628123
  3. Registered EUDAMED 697533962006MU

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  • Withdrawn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
CoralWell
Generic name
Ureteral introduction sheath
Device name
Single-use Ureteral Access Sheath
Model / reference
NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B
Primary DI / UDI-DI
06975339628123
Basic UDI-DI
697533962006MU
FDA product code
FED
EMDN code
U0299 Ureteral catheters - other
GMDN term
Ureteral introduction sheath
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

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 (K250452)

and 8 more cleared under K250452

Similar devices in this category

Other devices filed under URETERAL CATHETERS AND STENTS.

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)