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DemeSORB PGA188010B0P

by DemeTECH Corp

Ref NL262030F13M

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

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10652927698128 Basic UDI-DI 10652927698128UDI-DIDate13 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10652927698128 UDI-DI Date6 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 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  • Withdrawn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
DemeLON EUDAMED
DemeSORB GUDID
Generic Name
Polyester suture, bioabsorbable, multifilament, non-antimicrobial
Model / Reference
NL262030F13M EUDAMED
PGA188010B0P GUDID
Primary DI / UDI-DI
10652927698128
Basic UDI-DI
B-10652927698128
510(k) Number
FDA Product Code
GAM
EMDN Code
H010201010101 Polyamide monofilament with needle
GMDN Term
Polyester suture, bioabsorbable, multifilament, non-antimicrobial
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4493
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
NL262030F13M
GUDID
PGA188010B0P
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Polyester suture, bioabsorbable, multifilament, non-antimicrobial

Cleared under the same submission (K043539)

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