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Nidek Medical Products, Inc.

USA · Birmingham AL · www.nidekmedical.com

✓ Record-verifiedregistrations found in 11 marketsEU SRN US-MF-000007253

This company has registrations in European Union, United States, United Kingdom, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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

22UDI-DI device records

Class IIa 5Class IIb 17

USUnited StatesFDA openFDA

4listed device types

Class I 1Class II 3Class III 0

plus 6 registration records and 12 510(k)

UKUnited KingdomMHRA PARD

33registered device records

Class I 9Class IIa 21Class IIb 3

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

5 including historic records

TWTaiwanTFDA

3valid device licences

Class II 3

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

2active ARTG entries

IIa 2

HKHong KongMDACS

2valid listings

Class III 2

ILIsraelAMAR

7registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 2

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.

European Union103 raw hits, 81 excluded, 22 confirmed

United States6 registration records, 12 510(k), 0 PMA, 7 excluded

United Kingdom33 confirmed, 0 excluded

Brazil0 confirmed, 4 excluded

Saudi Arabia0 confirmed, 4 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: NIDEK MEDICAL PRODUCTS, INC. · NIDEK MEDICAL PRODUCTS, INCORPORATED

Regulatory identity

EU manufacturer SRN: US-MF-000007253
EU authorised representative: mdi Europa GmbH
UK responsible person: Advena Ltd

FDA 510(k) clearances by year

11988

11995

11996

11997

11998

12002

22004

12008

12010

12013

12020

FDA listed device types

Generator, Oxygen, Portable 1Compressor, Air, Portable 1Nebulizer (Direct Patient Interface) 1Flowmeter, Tube, Thorpe, Back-Pressure Compensated 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	00038214001698	Mark 5 Nuvo 10	Class IIb
EU	00038214001193	Mark 5 Nuvo 8	Class IIb
EU	00038214000233	Mark 5 Nuvo 8	Class IIb
EU	00038214002923	Mark 5 Nuvo	Class IIb
UK	45753	AUTO LENSMETER	Class I
UK	36386	AUTO REF/KERATOMETER	Class IIa
UK	12811	AUTO REF/KERATO/TONO/PACHYMETER TONOREF III	Class IIa
US	K192693	Nuvo Nano Portable Oxygen Concentrator	2020-05-07
US	K123738	MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD	2013-02-28
US	K093308	MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD	2010-01-14