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APTIS MEDICAL, LLC.

USA · Glenview

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Singapore, 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

10listed device types

Class I 9Class II 1Class III 0

plus 14 registration records and 5 510(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

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IIa 1IIb 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States14 registration records, 5 510(k), 0 PMA

Manufacturer names merged into this page: APTIS MEDICAL, LLC.

FDA 510(k) clearances by year

22005 · K053119

12008 · K082839

12015 · K142569

12019 · K190599

FDA listed device types

showing 8 of 10

Prosthesis, Wrist, Hemi-, Ulnar 1Screwdriver 1Template 1Reamer 1Bit, Drill 1Gauge, Depth 1Tray, Surgical 1Impactor 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K190599	Aptis Medical Distal Radio Ulnar Joint Implant	2019-05-03
US	K142569	Aptis Medical Distal Radio Ulnar Joint Implant	2015-04-03
US	K082839	DISTAL RADIO-ULNAR JOINT IMPLANT	2008-10-24

APTIS MEDICAL, LLC.

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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