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Klockner 82 11 01 02

by Soadco, S.L.

Part of a family of 116 devices: see the family page

Ref 82 11 01 02Model Basic UDI

Klockner 82 11 01 02 is a Class I device made by Soadco, S.L., registered in EUDAMED on 1 Jun 2026 (Basic UDI-DI 84354516TF9N1P2) and listed in FDA GUDID since 12 Feb 2025 (UDI-DI 08435451650269), 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 Number84354516TF9N1P2 Basic UDI-DI 08435451650269UDI-DIDate1 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08435451650269 UDI-DI Date12 Feb 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 84354516TF9N1P2 registered 1 Jun 2026 Active
  • FDA GUDID UDI-DI 08435451650269 listed 12 Feb 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08435451650269
  2. Registered EUDAMED 84354516TF9N1P2

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  • Withdrawn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
i-KL 3 SCAN ABUTMENT EUDAMED
Klockner GUDID
Generic name
Dental milling system, CAD/CAM, laboratory
Model / Ref / Catalog
82 11 01 02, Basic UDI
Primary DI / UDI-DI
08435451650269
Basic UDI-DI
84354516TF9N1P2
FDA product code
NDP
EMDN code
P01020180 Dental implants - accessories
GMDN term
Dental milling system, CAD/CAM, laboratory
Device class
Class I
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 · 1 field differs

FieldEUDAMEDGUDID
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 08435451650269: EUDAMED states No, FDA GUDID states Yes.

Related devices

Category: Dental milling system, CAD/CAM, laboratory

Similar devices in this category

Other devices filed under DENTAL IMPLANTS - ACCESSORIES.

Other devices from Soadco, S.L.

See all devices from Soadco, S.L. →

Properties

  • Sterilise before use NoEUDAMEDYesGUDID
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)