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LOCATOR R-Tx 30016-01

by Zest Anchors, LLC

Ref 30016-01

LOCATOR R-Tx 30016-01 is a Class I device made by Zest Anchors, LLC, registered in EUDAMED on 9 Sep 2026 (Basic UDI-DI 08404811Z040EF) and listed in FDA GUDID since 6 Jul 2022 (UDI-DI 00840481110061), 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 Number08404811Z040EF Basic UDI-DI 00840481110061UDI-DIDate9 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840481110061 UDI-DI Date6 Jul 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08404811Z040EF registered 9 Sep 2026 Active
  • FDA GUDID UDI-DI 00840481110061 listed 6 Jul 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00840481110061
  2. Registered EUDAMED 08404811Z040EF

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  • Withdrawn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 analog
Device name
Locator R-Tx Analog
Model / reference
30016-01
Primary DI / UDI-DI
00840481110061
Basic UDI-DI
08404811Z040EF
FDA product code
NDP
EMDN code
P01020180 Dental implants - accessories
GMDN term
Dental implant analog
Device class
Class I
Regulation number
872.3980
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: Dental implant analog

Similar devices in this category

Other devices filed under DENTAL IMPLANTS - ACCESSORIES.

Other devices from Zest Anchors, LLC

See all devices from Zest Anchors, LLC →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)