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CeroFrict SML001-PT01

by SML Med-Tech Solutions Limited

Part of a family of 25 devices: see the family page

Ref SML001-PT01Model SML001-PT

CeroFrict SML001-PT01 is a device classified as Class IIa in the EU and Class II in the US made by SML Med-Tech Solutions Limited, registered in EUDAMED on 22 May 2026 (Basic UDI-DI 489712999SML001UV), cleared under FDA 510(k) K220884 on 17 Jan 2023 and listed in FDA GUDID since 17 Apr 2023 (UDI-DI 04897129990437), 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
European UnionCE/MDR EUDAMED Number489712999SML001UV Basic UDI-DI 04897129990437UDI-DIDate22 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04897129990437 UDI-DI Date17 Apr 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK220884 Date17 Jan 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 489712999SML001UV registered 22 May 2026 Active
  • FDA 510(k) K220884 decided 17 Jan 2023 Active
  • FDA GUDID UDI-DI 04897129990437 listed 17 Apr 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K220884
  2. Listed FDA GUDID 04897129990437
  3. Registered EUDAMED 489712999SML001UV

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  • Withdrawn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® EUDAMED
CeroFrict GUDID
Generic name
Endoscope air/water valve, single-use
Model / reference
SML001-PT01, SML001-PT
Primary DI / UDI-DI
04897129990437
Basic UDI-DI
489712999SML001UV
510(k) Number
FDA product code
ODC
EMDN code
G0380 Digestive endoscopy devices - accessories
GMDN term
Endoscope air/water valve, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Germany
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 (K220884)

and 8 more cleared under K220884

Similar devices in this category

Other devices filed under DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES.

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 (20, all answered No)