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TSX Implants TSX37B13

by ZimVie US Corp LLC

Ref TSX37B13

TSX Implants TSX37B13 is a device classified as Class IIb in the EU and Class II in the US made by ZimVie US Corp LLC, registered in EUDAMED on 20 Jul 2026 (Basic UDI-DI 844868B9HD) and listed in FDA GUDID since 26 Sep 2022 (UDI-DI 00844868045069), 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 Number844868B9HD Basic UDI-DI 00844868045069UDI-DIDate20 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00844868045069 UDI-DI Date26 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 844868B9HD registered 20 Jul 2026 Active
  • FDA GUDID UDI-DI 00844868045069 listed 26 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00844868045069
  2. Registered EUDAMED 844868B9HD

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  • Withdrawn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
TSX® Implant EUDAMED
TSX Implants GUDID
Generic name
Screw endosteal dental implant, two-piece
Device name
Friction-Fit Implants
Model / reference
TSX37B13
Primary DI / UDI-DI
00844868045069
Basic UDI-DI
844868B9HD
FDA product code
DZE
EMDN code
P01020101 Dental implants
GMDN term
Screw endosteal dental implant, two-piece
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.3640
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional
Size
Length — 13 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

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

Related devices

Category: Screw endosteal dental implant, two-piece

Similar devices in this category

Other devices filed under DENTAL IMPLANTS.

Other devices from ZimVie US Corp LLC

See all devices from ZimVie US Corp LLC →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)