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Excel Medical, Inc.

USA · Asbury Park

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 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

25listed device types

Class I 3Class II 22Class III 0

plus 39 registration records and 23 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 1Class II 3

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

SASaudi ArabiaSFDA

5registered imported devices

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

CACanadaMDALL

42active device licences

Class II 40Class III 1Class IV 1

77 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 States39 registration records, 23 510(k), 0 PMA, 13 excluded

Brazil4 confirmed, 1 excluded

Saudi Arabia5 confirmed, 0 excluded

Canada42 confirmed, 1 excluded

Manufacturer names merged into this page: NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK) · Excel Medical Products, Inc. · NATUS MEDICAL INCORPORATED ADBA EXCEL-TECH LTD (XLTEK) · Excel Medical Products, Inc · NATUS MEDICAL INCORPORATED, DBA EXCEL-TECH LTD. · Natus Medical Incorporated, DBA Excel - Tech Ltd. (XLTEK)

FDA 510(k) clearances by year

21988

11991

31992

21993

32016

12017

62018

12020

12021

22024

12026

FDA listed device types

showing 8 of 25

Electrode, Cortical 1Automatic Event Detection Software For Full-Montage Electroencephalograph 1Electromyograph, Diagnostic 1Stimulator, Electrical, Evoked Response 1System, Image Processing, Radiological 1Electrode, Cutaneous 1Abutment, Implant, Dental, Endosseous 1Non-Normalizing Quantitative Electroencephalograph Software 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250135	WAVE Clinical Platform (2.0.000)	2026-01-16
US	K242930	Natus BrainWatch System	2024-11-19
US	K233649	ALGO Pro Newborn Hearing Screener (ALGO Pro)	2024-03-08
BR	81021309001	EXCEL INFLATION DEVICE	Class I
BR	80102512057	SISTEMA AMPLIFICADOR EEG	Class II
BR	80102512138	Sistema XactTrace de Uso Único	Class II
SA	ME0000006691SFDAA00002	RetCam Envision Lens	—
SA	ME0000006691SFDAA00001	RetCam Envision System	—
CA	500	CEREBRAL FUNCTION MONITOR CFM 6000	Class III
CA	2069	ISOTRON 220 ISOTRON AND 1000 PLUS POWERED MUSCLE STIMULATOR	Class II
CA	2070	ISOTRON II, ISOTRON III, ISOTRON IV 2 CHANNEL ELECTRO MUSCLE STIMULATOR	Class II

Excel Medical, 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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