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DemeLON

by DemeTECH Corp 13 variants

Ref NL1063020F4P

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 22 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED Number1065292NL00010022 Basic UDI-DI 10652927223245UDI-DIDate13 Feb 2026RegisteredStatusActive
European UnionCE/MDR EUDAMED Number1065292NL00010022 Basic UDI-DI 10652927223245UDI-DIDate13 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10652927223245 UDI-DI Date18 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 22 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  • Withdrawn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

Generic Name
Nylon suture, non-bioabsorbable, monofilament
Model / Reference
NL1063020F4P
Primary DI / UDI-DI
10652927223245
Basic UDI-DI
1065292NL00010022, B-10652927223245
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 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

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