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Fisch reference caliper 10-659-04

by Spiggle & Theis Medizintechnik GmbH

Ref 10-659-04

Fisch reference caliper 10-659-04 is a Class I device made by Spiggle & Theis Medizintechnik GmbH, registered in EUDAMED on 30 Sep 2026 (Basic UDI-DI B-04250381848456) and listed in FDA GUDID since 13 Sep 2022 (UDI-DI 04250381848456), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04250381848456 Basic UDI-DI 04250381848456UDI-DIDate30 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250381848456 UDI-DI Date13 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04250381848456 registered 30 Sep 2026 Active
  • FDA GUDID UDI-DI 04250381848456 listed 13 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250381848456
  2. Registered EUDAMED B-04250381848456

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  • Withdrawn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
Fisch reference caliper
Generic name
Surgical depth gauge, reusable
Device name
Hooks, Needles, Perforators
Model / Ref / Catalog
10-659-04
Description
for stapes prostheses 0.4 mm, 16 cm
Primary DI / UDI-DI
04250381848456
Basic UDI-DI
B-04250381848456
FDA product code
JYJ
EMDN code
P020180 Otologic prostheses - accessories
GMDN term
Surgical depth gauge, 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: Surgical depth gauge, reusable

Similar devices in this category

Other devices filed under OTOLOGIC PROSTHESES.

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Properties

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