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Mikron Makina Sanayi Ticaret Co. , Ltd.

Türkiye · Ankara

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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

23listed device types

Class I 19Class II 4Class III 0

plus 21 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 2Class II 6

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

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States21 registration records, 6 510(k), 0 PMA, 1 excluded

Brazil8 confirmed, 0 excluded

Manufacturer names merged into this page: MIKRON MAKINA SANAYI VE TICARET LTD. STI. · MIKRON MAKINA SANAYI VE TICARET LTD. &#350.TI.

Same-named companies — This database also contains companies with near-identical names: Mikron Makina San. ve Tic. Ltd. Sti., Mikron Makina Sanayi VE Tic. Ltd. Sti., MIKRON MAKINA SANAYI VE TICARET LTD. Ş.TI., MIKRON MAKINA SANAYI VE TICARET LTD. STI.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12013 · K130073

12017 · K171497

22024 · K241657

12025 · K252781

12026 · K260277

FDA listed device types

showing 8 of 23

Template 1Impactor 1Instrument, Surgical, Non-Powered 1Screwdriver 1Reamer 1Guide, Drill, Ligament 1Gauge, Depth 1Orthopedic Manual Surgical Instrument 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260277	MIKRON TRAUMA BONE PLATE& SCREW SYSTEM	2026-08-13
US	K252781	MSFX MIKRON PEEK CAGES	2025-12-19
US	K241657	MSFX MIKRON SPINAL FIXATION SYSTEM	2024-09-30
BR	81256939002	KIT DE INSTRUMENTOS PARA PARAFUSO CERVICAL POSTERIOR	Class I
BR	81256939003	KIT PARA IMPLANTE INTERESPINHOSO	Class I
BR	81256939004	KIT DE INSTRUMENTOS DE PARAFUSO POSTERIOR PEDIÁTRICO	Class II

Mikron Makina Sanayi Ticaret Co. , Ltd.

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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