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LOCATOR R-Tx 30028-01

by Zest Anchors, LLC

Part of a family of 8 devices: see the family page

Ref 30028-01

LOCATOR R-Tx 30028-01 is a device classified as Class IIa in the EU and Class I in the US made by Zest Anchors, LLC, registered in EUDAMED on 24 Aug 2026 (Basic UDI-DI 08404811Z043EM) and listed in FDA GUDID since 6 Jul 2022 (UDI-DI 00840481126055), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08404811Z043EM Basic UDI-DI 00840481126055UDI-DIDate24 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840481126055 UDI-DI Date6 Jul 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08404811Z043EM registered 24 Aug 2026 Active
  • FDA GUDID UDI-DI 00840481126055 listed 6 Jul 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00840481126055
  2. Registered EUDAMED 08404811Z043EM

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  • Withdrawn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
LOCATOR R-Tx
Generic name
Dental implant suprastructure, permanent, preformed
Device name
LOCATOR R-Tx INSERT
Model / reference
30028-01
Primary DI / UDI-DI
00840481126055
Basic UDI-DI
08404811Z043EM
FDA product code
EGG
EMDN code
Q01020601 Mobile dental prostheses
GMDN term
Dental implant suprastructure, permanent, preformed
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.3165
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
High-level Disinfectant

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I
ImplantableEUDAMED
No
GUDID
Yes

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: Dental implant suprastructure, permanent, preformed

Similar devices in this category

Other devices filed under MOBILE DENTAL PROSTHESES.

Other devices from Zest Anchors, LLC

See all devices from Zest Anchors, LLC →

Properties

  • Sterilise before use
  • Single use
  • Implantable NoEUDAMEDYesGUDID
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (18, all answered No)