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Redon guide needle 80-472-35

by Spiggle & Theis Medizintechnik GmbH

Ref 80-472-35

Redon guide needle 80-472-35 is a Class I device made by Spiggle & Theis Medizintechnik GmbH, registered in EUDAMED on 30 Sep 2026 (Basic UDI-DI B-04250676734105) and listed in FDA GUDID since 19 Sep 2025 (UDI-DI 04250676734105), 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-04250676734105 Basic UDI-DI 04250676734105UDI-DIDate30 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250676734105 UDI-DI Date19 Sep 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04250676734105 registered 30 Sep 2026 Active
  • FDA GUDID UDI-DI 04250676734105 listed 19 Sep 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250676734105
  2. Registered EUDAMED B-04250676734105

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  • Withdrawn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
Redon guide needle
Generic name
Needle guide, reusable
Device name
Hooks, Needles, Perforators
Model / Ref / Catalog
80-472-35
Description
lancet tip, slight curve 3.5 mm, 18.5 cm
Primary DI / UDI-DI
04250676734105
Basic UDI-DI
B-04250676734105
FDA product code
LRC
EMDN code
A019009 Drainage needles
GMDN term
Needle guide, 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

Related devices

Category: Needle guide, reusable

Other devices from Spiggle & Theis Medizintechnik GmbH

See all devices from Spiggle & Theis Medizintechnik GmbH →

Properties

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