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DemeBOND

by DemeTECH Corp 195 variants

Part of a family of 235 devices: see the family page

Ref PB19401

DemeBOND (PB19401) is a device classified as Class IIb in the EU and Class II in the US made by DemeTECH Corp, registered in EUDAMED on 27 Mar 2026 (Basic UDI-DI 1065292PB000100VT), cleared under FDA 510(k) K023030 on 18 Jun 2003 and listed in FDA GUDID since 20 Jun 2019 (UDI-DI 10652927182405), active as of 22 Oct 2026.

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

CE MDR 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K023030

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED Number1065292PB000100VT Basic UDI-DI 10652927182405UDI-DIDate27 Mar 2026RegisteredStatusActive
European UnionCE/MDR EUDAMED Number1065292PB000100VT Basic UDI-DI 10652927182405UDI-DIDate27 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10652927182405 UDI-DI Date20 Jun 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK023030 Date18 Jun 2003DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 1065292PB000100VT registered 27 Mar 2026 Active· +1 more in the status table
  • FDA 510(k) K023030 decided 18 Jun 2003 Active
  • FDA GUDID UDI-DI 10652927182405 listed 20 Jun 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K023030
  2. Listed FDA GUDID 10652927182405
  3. Registered EUDAMED 1065292PB000100VT

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Polyester suture, non-bioabsorbable, multifilament, non-antimicrobial
Model / reference
PB19401
Primary DI / UDI-DI
10652927182405
Basic UDI-DI
1065292PB000100VT, B-10652927182405
510(k) Number
FDA product code
GAT
EMDN code
H010201020203 Polyester multifilament without needle
GMDN term
Polyester suture, non-bioabsorbable, multifilament, non-antimicrobial
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.5000
EU registration type
Standard device
Legacy device (under a directive)
EU market of registration
Hungary
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.

Manufacturer details

EUDAMED SRN
US-MF-000026972
Authorised representative
Obelis s.a. BE-AR-000000106

Similar devices in this category

Other devices filed under POLYESTER MULTIFILAMENT.

Other devices from DemeTECH Corp

See all devices from DemeTECH Corp →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)