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Hooks, Needles, Perforators

by SPIGGLE & THEIS Medizintechnik GmbH 5 variants

Ref 85-900-01

Hooks, Needles, Perforators (85-900-01) is a Class I device made by SPIGGLE & THEIS Medizintechnik GmbH, registered in EUDAMED on 30 Sep 2026 (Basic UDI-DI B-04250676710017) and listed in FDA GUDID since 29 Sep 2025 (UDI-DI 04250676710017), 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-04250676710017 Basic UDI-DI 04250676710017UDI-DIDate30 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250676710017 UDI-DI Date29 Sep 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04250676710017 registered 30 Sep 2026 Active
  • FDA GUDID UDI-DI 04250676710017 listed 29 Sep 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250676710017
  2. Registered EUDAMED B-04250676710017

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  • Withdrawn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
Hook
Generic name
Soft-tissue surgical hook, reusable
Device name
Hooks, Needles, Perforators
Model / Ref / Catalog
85-900-01
Description
curved, blunt 10.5 cm
Primary DI / UDI-DI
04250676710017
Basic UDI-DI
B-04250676710017
FDA product code
JYL
EMDN code
L031102 Exploration probes, 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

Manufacturer details

EUDAMED SRN
DE-MF-000006647

Similar devices in this category

Other devices filed under EXPLORATION PROBES, REUSABLE.

Other devices from SPIGGLE & THEIS Medizintechnik GmbH

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Properties

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