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DemeBOND

by DemeTECH Corp 195 variants

Ref PB5X1401, PX280130B1P

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

CE MDR CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED Number1065292PB000100VT Basic UDI-DI Date27 Mar 2026RegisteredStatusActive
European UnionCE/MDR EUDAMED Number1065292PB000100VT Basic UDI-DI Date27 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10652927778141 UDI-DI Date21 Dec 2022ListedStatusListed 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 24 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
DemeBOND EUDAMED
DemeDIOX EUDAMEDGUDID
Generic Name
Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Model / Reference
PB5X1401, PX280130B1P
Primary DI / UDI-DI
10652927778141, 10652927775423
Basic UDI-DI
1065292PB000100VT, B-10652927778141, B-10652927775423
510(k) Number
FDA Product Code
NEW
EMDN Code
H010201020203, H010101010101
GMDN Term
Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Device Class
Class IIb EUDAMED
Class III EUDAMED
Class II GUDID
Regulation Number
878.4840
EU market of registration
Czechia
Poland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
Class III
GUDID
Class II

Manufacturer details

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

Other devices from DemeTECH Corp

See all devices from DemeTECH Corp →

Properties

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

Other properties (18)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: 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