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DemeDIOX PX580040BI22M

by DemeTECH Corp

Ref PX580040BI22M

DemeDIOX PX580040BI22M is a device classified as Class III in the EU and Class II in the US made by DemeTECH Corp, registered in EUDAMED on 27 Jul 2026 (Basic UDI-DI B-10652927673507), cleared under FDA 510(k) K082097 on 8 Jan 2010 and listed in FDA GUDID since 15 Jan 2020 (UDI-DI 10652927673507), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K082097

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10652927673507 Basic UDI-DI 10652927673507UDI-DIDate27 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10652927673507 UDI-DI Date15 Jan 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK082097 Date8 Jan 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10652927673507 registered 27 Jul 2026 Active
  • FDA 510(k) K082097 decided 8 Jan 2010 Active
  • FDA GUDID UDI-DI 10652927673507 listed 15 Jan 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K082097
  2. Listed FDA GUDID 10652927673507
  3. Registered EUDAMED B-10652927673507

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  • Withdrawn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

Trade name
DemeDIOX
Generic name
Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Model / reference
PX580040BI22M
Primary DI / UDI-DI
10652927673507
Basic UDI-DI
B-10652927673507
510(k) Number
FDA product code
NEW
EMDN code
H010101010101 Polydioxanone monofilament with needle for open surgery
GMDN term
Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Device class
Class III EUDAMED
Class II GUDID
Regulation number
878.4840
EU registration type
Legacy device (under a directive)
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III 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: Polyester suture, bioabsorbable, monofilament, non-antimicrobial

Cleared under the same submission (K082097)

and 8 more cleared under K082097

Similar devices in this category

Other devices filed under POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR OPEN SURGERY.

Other devices from DemeTECH Corp

See all devices from DemeTECH Corp →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)