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Klockner 1300

by Soadco, S.L.

Part of a family of 169 devices: see the family page

Ref 1300Model Basic UDI

Klockner 1300 is a device classified as Class IIa in the EU and Class I in the US made by Soadco, S.L., registered in EUDAMED on 1 Jun 2026 (Basic UDI-DI 84354516TF13QH) and listed in FDA GUDID since 22 Nov 2022 (UDI-DI 08435451661067), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number84354516TF13QH Basic UDI-DI 08435451661067UDI-DIDate1 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08435451661067 UDI-DI Date22 Nov 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 84354516TF13QH registered 1 Jun 2026 Active
  • FDA GUDID UDI-DI 08435451661067 listed 22 Nov 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08435451661067
  2. Registered EUDAMED 84354516TF13QH

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  • Withdrawn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
Countersink Drill Ø4.2mm EUDAMED
Klockner GUDID
Generic name
Steel dental bur, reusable
Model / Ref / Catalog
1300, Basic UDI
Primary DI / UDI-DI
08435451661067 EUDAMED
08435451604224 GUDID
Basic UDI-DI
84354516TF13QH
FDA product code
NDP
EMDN code
Q010399 Surgical dental devices - other
GMDN term
Steel dental bur, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.3980
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
08435451661067
GUDID
08435451604224
Device classEUDAMED
Class IIa
GUDID
Class I

The registries describe this device under different primary UDI-DIs (EUDAMED lists 08435451661067; FDA GUDID lists 08435451604224), so their flags are not compared. 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: Steel dental bur, reusable

Similar devices in this category

Other devices filed under SURGICAL DENTAL DEVICES - OTHER.

Other devices from Soadco, S.L.

See all devices from Soadco, S.L. →

Properties

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