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drill 42210019

by implantcast GmbH

Ref 42210019Model UKNB04D1

drill 42210019 is a device classified as Class IIa in the EU and Class I in the US made by implantcast GmbH, registered in EUDAMED on 13 Jul 2026 (Basic UDI-DI 4048844UKNB04D1ZM) and listed in FDA GUDID since 13 Jun 2022 (UDI-DI 04048844041779), 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 Number4048844UKNB04D1ZM Basic UDI-DI 04048844041779UDI-DIDate13 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048844041779 UDI-DI Date13 Jun 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4048844UKNB04D1ZM registered 13 Jul 2026 Active
  • FDA GUDID UDI-DI 04048844041779 listed 13 Jun 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04048844041779
  2. Registered EUDAMED 4048844UKNB04D1ZM

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  • Withdrawn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
drill
Generic name
Cannulated surgical drill bit, reusable
Model / reference
42210019, UKNB04D1
Primary DI / UDI-DI
04048844041779
Basic UDI-DI
4048844UKNB04D1ZM
Direct marketing DI
04048844041779
FDA product code
HTW
EMDN code
Z12130503 Orthopaedic surgical drills
GMDN term
Cannulated surgical drill bit, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Cannulated surgical drill bit, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGICAL DRILLS.

Other devices from implantcast GmbH

See all devices from implantcast GmbH →

Properties

  • Sterilise before use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)