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ASEPTICO, INCORPORATED

USA · Woodinville

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Saudi Arabia, Canada, Taiwan, Singapore, 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

21listed device types

Class I 19Class II 2Class III 0

plus 31 registration records and 18 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

4registered imported devices

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

CACanadaMDALL

21active device licences

Class II 21

48 including historic records

TWTaiwanTFDA

5valid device licences

Class I 5

SGSingaporeHSA SMDR

4device registrations

CLASS B 4

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

14active ARTG entries

Class I 6IIa 8

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

5active registrations

Class 2a 5

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 States31 registration records, 18 510(k), 0 PMA

Saudi Arabia4 confirmed, 0 excluded

Canada21 confirmed, 0 excluded

Manufacturer names merged into this page: ASEPTICO, INC. · ASEPTICO, INCORPORATED · Aseptico, Inc. · Aseptico Inc.

FDA 510(k) clearances by year

11988

11989

11991

11992

11993

22002

22003

22005

12007

32011

12013

12014

12015

FDA listed device types

showing 8 of 21

Motor, Surgical Instrument, Ac-Powered 1Handpiece, Water-Powered 1Frame, Rubber Dam 1Handpiece, Air-Powered, Dental 1Unit, Operative Dental 1Chair, Dental, Without Operative Unit 1Instruments, Dental Hand 1Handpiece, Contra- And Right-Angle Attachment, Dental 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K150129	AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION)	2015-05-28
US	K142124	AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM	2014-12-31
US	K130693	AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM	2013-08-14
SA	ME0000000563SFDAA00009	AMC‑25	—
SA	ME0000000563SFDAA00013	Airpac III	—
CA	9744	PERISTALTIC WATER PUMP(MODEL AEU-7)	Class II
CA	9746	MODEL AEU-227	Class II
CA	9756	AEU-707 AV2 DENTAL DRILL SYSTEM	Class II

ASEPTICO, INCORPORATED

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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