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Demetech PTFE TE654016F4P

by DemeTECH Corp

Ref TE654016F4P

Demetech PTFE TE654016F4P 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-10652927670155), cleared under FDA 510(k) K181578 on 11 Oct 2018 and listed in FDA GUDID since 9 Jul 2019 (UDI-DI 10652927670155), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K181578

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10652927670155 Basic UDI-DI 10652927670155UDI-DIDate15 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10652927670155 UDI-DI Date9 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK181578 Date11 Oct 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10652927670155 registered 15 Jul 2026 Active
  • FDA 510(k) K181578 decided 11 Oct 2018 Active
  • FDA GUDID UDI-DI 10652927670155 listed 9 Jul 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K181578
  2. Listed FDA GUDID 10652927670155
  3. Registered EUDAMED B-10652927670155

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  • Withdrawn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
Demetech PTFE
Generic name
Polyolefin/fluoropolymer suture, monofilament
Model / reference
TE654016F4P
Primary DI / UDI-DI
10652927670155
Basic UDI-DI
B-10652927670155
510(k) Number
FDA product code
NBY
EMDN code
H010201010501 Polytetrafluoroethylene (ptfe) monofilament with needle
GMDN term
Polyolefin/fluoropolymer suture, monofilament
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.5035
EU registration type
Legacy device (under a directive)
EU market of registration
Spain
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: Polyolefin/fluoropolymer suture, monofilament

Cleared under the same submission (K181578)

and 8 more cleared under K181578

Similar devices in this category

Other devices filed under POLYTETRAFLUOROETHYLENE (PTFE) 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)