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Tuff Implant NMSF4216

by Noris Medical Ltd

Ref NMSF4216

Tuff Implant NMSF4216 is a device classified as Class IIb in the EU and Class II in the US made by Noris Medical Ltd, registered in EUDAMED on 28 Jun 2026 (Basic UDI-DI B-07290108812817) and listed in FDA GUDID since 15 Jul 2017 (UDI-DI 07290108812817), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

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/MDD EUDAMED NumberB-07290108812817 Basic UDI-DI 07290108812817UDI-DIDate28 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290108812817 UDI-DI Date15 Jul 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-07290108812817 registered 28 Jun 2026 Active
  • FDA GUDID UDI-DI 07290108812817 listed 15 Jul 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07290108812817
  2. Registered EUDAMED B-07290108812817

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Tuff Int. Hex Ti. Implant EUDAMED
Tuff Implant GUDID
Generic name
Screw endosteal dental implant, two-piece
Device name
Classic Implants Hex
Model / Ref / Catalog
NMSF4216
Primary DI / UDI-DI
07290108812817
Basic UDI-DI
B-07290108812817
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
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

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 Noris Medical Ltd

See all devices from Noris Medical Ltd →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)