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Eardrum punch 15-761-00

by Spiggle & Theis Medizintechnik GmbH

Ref 15-761-00

Eardrum punch 15-761-00 is a Class I device made by Spiggle & Theis Medizintechnik GmbH, registered in EUDAMED on 30 Sep 2026 (Basic UDI-DI B-04250676728562) and listed in FDA GUDID since 14 Sep 2022 (UDI-DI 04250676728562), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04250676728562 Basic UDI-DI 04250676728562UDI-DIDate30 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250676728562 UDI-DI Date14 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04250676728562 registered 30 Sep 2026 Active
  • FDA GUDID UDI-DI 04250676728562 listed 14 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250676728562
  2. Registered EUDAMED B-04250676728562

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  • Withdrawn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
Eardrum punch
Generic name
Bone-coring punch, reusable
Device name
Punches
Model / Ref / Catalog
15-761-00
Description
to roughen the tympanic membrane WL 9 cm
Primary DI / UDI-DI
04250676728562
Basic UDI-DI
B-04250676728562
FDA product code
LRC
EMDN code
L149012 ENT surgery punches, reusable
GMDN term
Bone-coring punch, 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: Bone-coring punch, reusable

Similar devices in this category

Other devices filed under ENT INSTRUMENTS, REUSABLE - VARIOUS.

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)