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Bone Screw Ti.

by NORIS MEDICAL Ltd 6 variants

Part of a family of 7 devices: see the family page

Ref NMBS1612

Bone Screw Ti. (NMBS1612) is a device classified as Class IIa in the EU and Class I in the US made by Noris Medical Ltd, registered in EUDAMED on 27 May 2026 (Basic UDI-DI 729010881FixationScrew1SL) and listed in FDA GUDID since 10 Nov 2025 (UDI-DI 07290108818192), 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 Number729010881FixationScrew1SL Basic UDI-DI 07290108818192UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290108818192 UDI-DI Date10 Nov 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 729010881FixationScrew1SL registered 27 May 2026 Active
  • FDA GUDID UDI-DI 07290108818192 listed 10 Nov 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07290108818192
  2. Registered EUDAMED 729010881FixationScrew1SL

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  • Withdrawn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
Bone Screw Ti. EUDAMED
Fixation screw GUDID
Generic name
Dental implantation drilling template stabilization bolt
Device name
Fixation screws and pins
Model / Ref / Catalog
NMBS1612
Primary DI / UDI-DI
07290108818192
Basic UDI-DI
729010881FixationScrew1SL
FDA product code
DZA
EMDN code
Q010399 Surgical dental devices - other
GMDN term
Dental implantation drilling template stabilization bolt
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.4130
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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.

Manufacturer details

EUDAMED SRN
IL-MF-000008710
Authorised representative
AR Experts B.V. NL-AR-000023989

Similar devices in this category

Other devices filed under SURGICAL DENTAL DEVICES - OTHER.

Other devices from Noris Medical Ltd

See all devices from Noris Medical Ltd →

Properties

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