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DemeCAPRONE MO283031B0P

by DemeTECH Corp

Ref MO283031B0P

DemeCAPRONE MO283031B0P is a device classified as Class III in the EU and Class II in the US made by DemeTECH Corp, registered in EUDAMED on 23 Jul 2026 (Basic UDI-DI B-10652927389613), cleared under FDA 510(k) K130083 on 17 Jul 2013 and listed in FDA GUDID since 20 Jun 2019 (UDI-DI 10652927389613), 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) K130083

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-10652927389613 Basic UDI-DI 10652927389613UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10652927389613 UDI-DI Date20 Jun 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK130083 Date17 Jul 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10652927389613 registered 23 Jul 2026 Active
  • FDA 510(k) K130083 decided 17 Jul 2013 Active
  • FDA GUDID UDI-DI 10652927389613 listed 20 Jun 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K130083
  2. Listed FDA GUDID 10652927389613
  3. Registered EUDAMED B-10652927389613

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  • Withdrawn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
DemeCAPRONE
Generic name
Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Model / reference
MO283031B0P
Primary DI / UDI-DI
10652927389613
Basic UDI-DI
B-10652927389613
510(k) Number
FDA product code
GAM
EMDN code
H010101010301 Poliglecaprone and derivatives monofilament with needle
GMDN term
Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Device class
Class III EUDAMED
Class II GUDID
Regulation number
878.4493
EU registration type
Legacy device (under a directive)
EU market of registration
Cyprus
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 (K130083)

and 8 more cleared under K130083

Similar devices in this category

Other devices filed under POLIGLECAPRONE AND DERIVATIVES MONOFILAMENT.

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)