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DemeBOND PB3X9500

by DemeTECH Corp

Ref PB3X9500

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Overview

A comprehensive medical device directory for the DemeBOND suture. Learn about its features, compliance, and FAQs.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10652927669364 Basic UDI-DI 10652927669364UDI-DIDate15 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10652927669364 UDI-DI Date21 Jun 2019ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
DemeBOND
Generic Name
Polyester suture, non-bioabsorbable, multifilament, non-antimicrobial
Model / Reference
PB3X9500
Primary DI / UDI-DI
10652927669364
Basic UDI-DI
B-10652927669364
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 market of registration
Czechia
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Polyester suture, non-bioabsorbable, multifilament

Cleared under the same submission (K023030)

Show all (12)

Other devices from DemeTECH Corp

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (16)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No