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Cottle mallet 20-400-18

by Spiggle & Theis Medizintechnik GmbH

Ref 20-400-18

Cottle mallet 20-400-18 is a Class I device made by Spiggle & Theis Medizintechnik GmbH, registered in EUDAMED on 30 Sep 2026 (Basic UDI-DI 425038185G1101RM) and listed in FDA GUDID since 14 Sep 2022 (UDI-DI 04250676733474), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

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/MDR EUDAMED Number425038185G1101RM Basic UDI-DI 04250676733474UDI-DIDate30 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250676733474 UDI-DI Date14 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 425038185G1101RM registered 30 Sep 2026 Active
  • FDA GUDID UDI-DI 04250676733474 listed 14 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250676733474
  2. Registered EUDAMED 425038185G1101RM

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Cottle mallet
Generic name
Surgical mallet
Device name
Mallets
Model / Ref / Catalog
20-400-18
Primary DI / UDI-DI
04250676733474
Basic UDI-DI
425038185G1101RM
Direct marketing DI
04250676733474
FDA product code
HXL
EMDN code
L0399 General surgery instruments, reusable - other
GMDN term
Surgical mallet
Device class
Class I
Regulation number
878.4800
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical mallet

Similar devices in this category

Other devices filed under GENERAL SURGERY INSTRUMENTS, REUSABLE.

Other devices from Spiggle & Theis Medizintechnik GmbH

See all devices from Spiggle & Theis Medizintechnik GmbH →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)