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DemeLON NL295016F13M

by DemeTECH Corp

Ref NL295016F13M

DemeLON NL295016F13M is a device classified as Class IIb in the EU and Class II in the US made by DemeTECH Corp, registered in EUDAMED on 15 Jul 2026 (Basic UDI-DI B-10652927419228), cleared under FDA 510(k) K023028 on 18 Jun 2003 and listed in FDA GUDID since 15 Jul 2019 (UDI-DI 10652927419228), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K023028

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10652927419228 Basic UDI-DI 10652927419228UDI-DIDate15 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10652927419228 UDI-DI Date15 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK023028 Date18 Jun 2003DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10652927419228 registered 15 Jul 2026 Active
  • FDA 510(k) K023028 decided 18 Jun 2003 Active
  • FDA GUDID UDI-DI 10652927419228 listed 15 Jul 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K023028
  2. Listed FDA GUDID 10652927419228
  3. Registered EUDAMED B-10652927419228

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  • Withdrawn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
DemeLON
Generic name
Nylon suture, non-bioabsorbable, monofilament
Model / reference
NL295016F13M
Primary DI / UDI-DI
10652927419228
Basic UDI-DI
B-10652927419228
510(k) Number
FDA product code
GAR
EMDN code
H010201010101 Polyamide monofilament with needle
GMDN term
Nylon suture, non-bioabsorbable, monofilament
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.5020
EU registration type
Legacy device (under a directive)
EU market of registration
Poland
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.

Related devices

Category: Nylon suture, non-bioabsorbable, monofilament

Cleared under the same submission (K023028)

and 8 more cleared under K023028

Similar devices in this category

Other devices filed under POLYAMIDE MONOFILAMENT WITH NEEDLE.

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)