Home›China›Fisher & Paykel Healthcare (Guangzhou) Ltd.

Fisher & Paykel Healthcare (Guangzhou) Ltd.

✓ Record-verifiedregistrations found in 10 marketsEU SRN NZ-MF-000002556Unified social credit code 91440116793452540Y

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong — 10 overseas markets. EU UDI-DI records ≥53, the first 300 verified individually. No China NMPA registrations were found.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

0China registrations

as of 2026-09-01

EUEuropean UnionEUDAMED

≥53UDI-DI device records

Class I 1Class IIa 45Class IIb 7

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

36listed device types

Class I 17Class II 19Class III 0

plus 275 registration records and 115 510(k)

UKUnited KingdomMHRA PARD

87registered device records

Class I 20Class IIa 57Class IIb 10

BRBrazilANVISA

74registered devices

Class I 4Class II 70

78 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

6active device licences

Class II 6

103 including historic records

TWTaiwanTFDA

42valid device licences

Class I 6Class II 36

SGSingaporeHSA SMDR

22device registrations

CLASS B 17CLASS C 5

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

122active ARTG entries

Class I 31IIa 66IIb 23Class Im (measuring) 1Class Is (sterile) 1

HKHong KongMDACS

18valid listings

Class II 14Class III 4

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.

European Union1,059 raw hits, 247 excluded, 53 confirmed. Large result set — only the first 300 verified

United States275 registration records, 115 510(k), 0 PMA

China0 certificates (Class III 0 / II 0 / I 0), as of 2026-09-01

United Kingdom87 confirmed, 5 excluded

Brazil74 confirmed, 0 excluded

Canada6 confirmed, 0 excluded

Manufacturer names merged into this page: FISHER & PAYKEL HEALTHCARE, LTD. · FISHER & PAYKEL HEALTHCARE, INC. · Fisher & Paykel Healthcare S.A.de C.V. · FISHER & PAYKEL HEALTHCARE S.A.DE C.V. · FISHER AND PAYKEL HEALTHCARE LTD. · FISHER & PAYKEL HEALTHCARE LIMITED

Regulatory identity

EU manufacturer SRN: NZ-MF-000002556
EU authorised representative: FISHER & PAYKEL HEALTHCARE SAS
UK responsible person: Fisher & Paykel Healthcare Limited
Unified social credit code: 91440116793452540Y
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 2006-10-13
Registered capital: CNY 2,500,000
Paid-in capital: CNY 2,500,000
Legal form: Limited liability company (wholly owned by a foreign corporation)
Industry classification: Software and IT services
Last approval date: 2025-05-23

Business registration data from Tianyancha, as of 2026-09-02. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA 510(k) clearances by year

32005

32006

32008

22009

42010

22011

52012

42013

22014

12015

12016

42017

32018

22019

32020

32021

32022

62023

72024

62025

FDA listed device types

showing 8 of 36

Nebulizer (Direct Patient Interface) 1Noninvasive Positive Airway Pressure System, Facility Use 1Ventilator, Continuous, Facility Use 1Ventilator, Emergency, Powered (Resuscitator) 1Mixer, Breathing Gases, Anesthesia Inhalation 1Filter, Bacterial, Breathing-Circuit 1Sv70 Ventilator 1Warmer, Infant Radiant 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	09420012479440	F&P OPTIPAP JUNIOR	Class IIa
EU	09420012407238	MR850	Class IIa
EU	09420012425881	F&P Eson	Class IIa
EU	09420012468697	F&P 820	Class IIa
UK	31286	WATER TRAP REUSABLE	Class IIa
UK	60778	PROBE 4-IN-1 MR860/MR880	Class IIa
UK	60778	CONNECTION KIT S/U DUAL HTD	Class I
US	K253479	Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)	2025-12-19
US	K250651	OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTIPAPPXXS); OptiPAP Junior Nasal Prongs XS (OPTIPAPPXS); OptiPAP Junior Nasal Prongs S (OPTIPAPPS); OptiPAP Junior Nasal Prongs M (OPTIPAPPM); OptiPAP Junior Nasal Prongs L (OPTIPAPPL); OptiPAP Junior Nasal Prongs XL (OPTIPAPPXL); OptiPAP Junior Nasal Mask XXS (OPTIPAPMXXS); OptiPAP Junior Nasal Mask XS (OPTIPAPMXS); OptiPAP Junior Nasal Mask S (OPTIPAPMS); OptiPAP Junior Nasal Mask M (OPTIPAPMM); OptiPAP Jun	2025-11-19
US	K252173	F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full	2025-09-10
BR	81447959052	Máscara Facial F&P Evora	Class II
BR	81447959045	Umidificador respiratório F&P 950	Class II
BR	81447959015	Cânula nasal Optiflow Junior	Class II
CA	405	AIR ENTRAINER	Class II
CA	11313	PATIENT WARMERS	Class II
CA	69140	NIV MASKS	Class II