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ELOS MEDTECH PINOL A/S

Denmark · Gorlose

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Australia, Hong Kong, Israel, Russia — 9 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

9listed device types

Class I 4Class II 5Class III 0

plus 33 registration records and 13 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 2

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

SASaudi ArabiaSFDA

5registered imported devices

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

CACanadaMDALL

2active device licences

Class III 2

4 including historic records

TWTaiwanTFDA

5valid device licences

Class I 2Class II 3

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

31active ARTG entries

Class I 25IIa 1IIb 5

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

6active registrations

Class 1 4Class 2a 1Class 2b 1

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.

Australia, Hong Kong, Saudi Arabia, Israel: under each source's terms, this site shows record counts and official links only — no record details on pages, in search, in the member area or in exports.

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 States33 registration records, 13 510(k), 0 PMA

Brazil2 confirmed, 0 excluded

Saudi Arabia5 confirmed, 0 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: ELOS MEDTECH PINOL A/S · Elos Medtech Pinol A/S

FDA 510(k) clearances by year

12018

12019

32020

12021

12022

22023

22024

12025

12026

FDA listed device types

showing 8 of 9

Dental Abutment Design Software For Dental Laboratory 1Abutment, Implant, Dental, Endosseous 1Hearing Aid, Bone Conduction 1Implant, Endosseous, Root-Form 1Drill, Bone, Powered 1Screwdriver 1Accessories, Implant, Dental, Endosseous 1Instrument, Ent Manual Surgical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253774	Elos Accurate® Denture Fixation System	2026-05-20
US	K251497	Elos Accurate Hybrid Base	2025-10-16
US	K242025	Elos Accurate® Hybrid Base	2024-12-10
BR	80117581169	Chave de Catraca Indicadora de Torque	Class I
BR	10064010283	Scan Body	Class I
CA	97258	FLEXLINK TIBASE	Class III
CA	99902	ELOS ACCURATE HYBRID BASE KIT	Class III

ELOS MEDTECH PINOL A/S

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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