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Neotech Products, Inc.

USA · Valencia

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Israel — 8 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

20listed device types

Class I 15Class II 5Class III 0

plus 21 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

22registered devices

Class I 16Class II 6

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

SASaudi ArabiaSFDA

20registered imported devices

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

CACanadaMDALL

1active device licences

Class II 1

TWTaiwanTFDA

11valid device licences

Class I 11

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

12active ARTG entries

Class I 12

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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, 2 excluded

Brazil22 confirmed, 0 excluded

Saudi Arabia20 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: NEOTECH PRODUCTS, LLC · NEOTECH PRODUCTS, INC. · NEOTECH PRODUCTS LLC.

FDA 510(k) clearances by year

21988 · K882203

11989 · K890425

11992 · K921024

11993 · K931727

12002 · K011564

FDA listed device types

showing 8 of 20

Pump, Breast, Non-Powered 1Support, Patient Position 1Container, Liquid Medication, Graduated 1Cannula, Nasal, Oxygen 1Pad, Neonatal Eye 1Specula Accessories 1Device, Fixation, Tracheal Tube 1Device, Intravascular Catheter Securement 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K011564	NEOLEAD	2002-01-03
US	K931727	URINARY DRAINAGE BAG CADDY	1993-07-23
US	K921024	URO-TOTE LEG BAG	1992-09-02
BR	80301130099	EZ-HOLD	Class I
BR	80301130101	NEOSNUG	Class I
BR	80301130083	RADIOLUCENT NEOLEAD ELETRODO NEONATAL PRÉ-CONECTADO	Class I
SA	ME0000011069SFDAA00183	LITTLE SUCKER	—
SA	ME0000011069SFDAA00001	NEOLEAD	—
CA	7462	NEOTECH MECONIUM ASPIRATOR	Class II

Neotech Products, 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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