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Amsino International, Inc.

USA · Pomona

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Singapore, Australia, Israel — 7 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

28510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 28 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

9registered devices

Class I 3Class II 6

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

SASaudi ArabiaSFDA

8registered imported devices

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

CACanadaMDALL

4active device licences

Class II 4

33 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

16active ARTG entries

Class I 3IIa 5Class Im (measuring) 5Class Is (sterile) 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

7registrations

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 States0 registration records, 28 510(k), 0 PMA, 8 excluded

Brazil9 confirmed, 1 excluded

Saudi Arabia8 confirmed, 0 excluded

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: AMSINO INTERNATIONAL, INC. · AMSINO INTERNATIONAL INC · Amsino international Inc. · Amsino International Inc.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252543	AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)	2026-05-04
US	K220230	AMSure Enteral Feeding Pump	2022-11-10
US	K220267	AMSafe NeuFlo Needleless Connector	2022-10-07
BR	80686360124	EZE-VAC Canister (Coletor)	Class I
BR	80686360125	RECEPTAL Canister (Coletor)	Class I
BR	80686360126	RECEPTAL Liner (Liner Coletor)	Class I
SA	ME0000004077SFDAA00069	1.0 Rover for Waste Fluid Management system	—
SA	ME0000004077SFDAA00079	Docking station for waste fluid management system	—
CA	78166	AMSURE GASTROSTOMY TUBE	Class II
CA	78299	AMSURE WOUND DRAINAGE SUCTION RESERVOIR SETS	Class II
CA	82688	AMSINO DISPOSABLE SYRINGE WITH NEEDLE	Class II

Amsino International, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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