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C235

by EKOM spol. s r.o. 5 variants

Ref 430402009-010Model C235

C235 is a device classified as Class IIb in the EU and Class II in the US made by EKOM spol. s r.o., registered in EUDAMED on 24 Jun 2026 (Basic UDI-DI B-08586014620165), cleared under FDA 510(k) K091871 on 23 Oct 2009 and listed in FDA GUDID since 13 May 2016 (UDI-DI 08586014620165), active as of 13 Oct 2026.

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

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 13 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K091871

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 13 Oct 2026.

Regulatory status

as of registry sync 13 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08586014620165 Basic UDI-DI 08586014620165UDI-DIDate24 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08586014620165 UDI-DI Date13 May 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK091871 Date23 Oct 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08586014620165 registered 24 Jun 2026 Active
  • FDA 510(k) K091871 decided 23 Oct 2009 Active
  • FDA GUDID UDI-DI 08586014620165 listed 13 May 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K091871
  2. Listed FDA GUDID 08586014620165
  3. Registered EUDAMED B-08586014620165

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Medical device air compressor
Device name
Medical compressor
Model / reference
C235, 430402009-010
Primary DI / UDI-DI
08586014620165
Basic UDI-DI
B-08586014620165
510(k) Number
FDA product code
BTI
EMDN code
R9099 Respiratory and anaesthesia devices - other
GMDN term
Medical device air compressor
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
868.6250
EU registration type
Legacy device (under a directive)
EU market of registration
Slovakia
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Medical device air compressor

Cleared under the same submission (K091871)

and 8 more cleared under K091871

Similar devices in this category

Other devices filed under RESPIRATORY AND ANAESTHESIA DEVICES - OTHER.

Other devices from EKOM spol. s r.o.

See all devices from EKOM spol. s r.o. →

Properties

  • Serial number
Other properties (22, all answered No)