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CeroFrict SML002-LP07

by SML Med-Tech Solutions Limited

CeroFrict SML002-LP07 is a Class II device made by SML Med-Tech Solutions Limited, cleared under FDA 510(k) K220884 on 17 Jan 2023, registered in EUDAMED and listed in FDA GUDID since 20 Feb 2023 (UDI-DI 04897129990314), 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) K220884

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 Number04897129990314 UDI-DI Date20 Feb 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK220884 Date17 Jan 2023DecidedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K220884 decided 17 Jan 2023 Active
  • EUDAMED Active
  • FDA GUDID UDI-DI 04897129990314 listed 20 Feb 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K220884
  2. Listed FDA GUDID 04897129990314

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  • Withdrawn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
CeroFrict
Generic name
Endoscope air/water valve, single-use
Model / reference
SML002-LP07
Primary DI / UDI-DI
04897129990314
510(k) Number
FDA product code
ODC
GMDN term
Endoscope air/water valve, single-use
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Endoscope channel support kitEndoscope suction valve, single-useEndoscope air/water valve, single-useLuminal device flushing tubing set, single-use

Cleared under the same submission (K220884)

and 8 more cleared under K220884

Similar devices

Other devices filed under FDA product code ODC (Endoscope Channel Accessory).

Other devices from SML Med-Tech Solutions Limited

See all devices from SML Med-Tech Solutions Limited →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)