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Neoss Limited

Sweden · Harrogate

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Australia, Israel — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

13listed device types

Class I 4Class II 8Class III 0unclassified 1

plus 23 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

1 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

19active ARTG entries

Class I 7IIa 7IIb 4Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States23 registration records, 10 510(k), 0 PMA

Manufacturer names merged into this page: NEOSS AB · NEOSS LTD

FDA 510(k) clearances by year

12005

12007

32009

12012

22015

12020

12022

FDA listed device types

showing 8 of 13

Bone Grafting Material, Animal Source 1Barrier, Animal Source, Intraoral 1Screw, Fixation, Intraosseous 1Barrier, Synthetic, Intraoral 1System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations 1Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene 1Abutment, Implant, Dental, Endosseous 1Implant, Endosseous, Root-Form 1

Market	Identifier	Name	Class / date
US	K211396	Neoss Individual Prosthetics	2022-05-17
US	K201561	Membrane Screws and Membrane Tacks	2020-10-05
US	K150669	Neoss TiBase, Neoss CoCr Abutments (Mono and Multi)	2015-10-08

Neoss Limited

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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