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Atc Technologies, Inc.

USA · Wilmington

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 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

15listed device types

Class I 3Class II 11Class III 0unclassified 1

plus 17 registration records and 4 510(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

1active device licences

Class II 1

5 including historic records

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 States17 registration records, 4 510(k), 0 PMA, 1 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: ATC TECHNOLOGIES INC.

FDA 510(k) clearances by year

11998 · K983623

12000 · K994319

12001 · K010473

12013 · K121343

FDA listed device types

showing 8 of 15

Electrosurgical, Cutting & Coagulation & Accessories 1Fastener, Fixation, Biodegradable, Soft Tissue 1Endoscopic Tissue Approximation Device 1Device, Biopsy, Endomyocardial 1Hysteroscope (And Accessories) 1Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) 1Endoscopic Grasping/Cutting Instrument, Non-Powered 1Lens, Contact, Polymethylmethacrylate, Diagnostic 1

Market	Identifier	Name	Class / date
US	K121343	MODULAP LOOP	2013-06-14
US	K010473	SPARROWHAWK DISPOSABLE	2001-06-06
US	K994319	MODULAP	2000-03-20
CA	81466	SPARROWHAWK ENDOMYOCARDIAL BIOPSY FORCEPS	Class II

Atc Technologies, Inc.

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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