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Rasps, Saws

by SPIGGLE & THEIS Medizintechnik GmbH 2 variants

Ref 20-427-19

Rasps, Saws (20-427-19) is a Class I device made by SPIGGLE & THEIS Medizintechnik GmbH, registered in EUDAMED on 30 Sep 2026 (Basic UDI-DI B-04250676732187) and listed in FDA GUDID since 25 Sep 2025 (UDI-DI 04250676732187), 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-04250676732187 Basic UDI-DI 04250676732187UDI-DIDate30 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250676732187 UDI-DI Date25 Sep 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04250676732187 registered 30 Sep 2026 Active
  • FDA GUDID UDI-DI 04250676732187 listed 25 Sep 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250676732187
  2. Registered EUDAMED B-04250676732187

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  • Withdrawn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
Nasal rasp
Generic name
Nasal file/rasp
Device name
Rasps, Saws
Model / Ref / Catalog
20-427-19
Description
fig. 5/6, fine/medium, double ended, TC golden handle, 21 cm
Primary DI / UDI-DI
04250676732187
Basic UDI-DI
B-04250676732187
FDA product code
KBA
EMDN code
L140205 Nasal and paranasal cavity surgery rasps and knives, reusable
GMDN term
Nasal file/rasp
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 NASAL AND PARANASAL CAVITY SURGERY INSTRUMENTS, 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)