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Knot tier 40-370-21

by Spiggle & Theis Medizintechnik GmbH

Ref 40-370-21

Knot tier 40-370-21 is a Class I device made by Spiggle & Theis Medizintechnik GmbH, registered in EUDAMED on 30 Sep 2026 (Basic UDI-DI B-04250381888391) and listed in FDA GUDID since 26 Sep 2022 (UDI-DI 04250381888391), active as of 23 Oct 2026.

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

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04250381888391 Basic UDI-DI 04250381888391UDI-DIDate30 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250381888391 UDI-DI Date26 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04250381888391 registered 30 Sep 2026 Active
  • FDA GUDID UDI-DI 04250381888391 listed 26 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250381888391
  2. Registered EUDAMED B-04250381888391

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  • Withdrawn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
Knot tier
Generic name
Soft-tissue surgical hook, reusable
Device name
Hooks, Needles, Perforators
Model / Ref / Catalog
40-370-21
Description
fork shaped, blunt 20.5 cm
Primary DI / UDI-DI
04250381888391
Basic UDI-DI
B-04250381888391
FDA product code
LRC
EMDN code
L0201 Needles and applicators for ligatures, reusable
GMDN term
Soft-tissue surgical hook, reusable
Device class
Class I
Regulation number
874.4420
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices in this category

Other devices filed under NEEDLES AND APPLICATORS FOR LIGATURES, REUSABLE.

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Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)