HomeChinaNINGBO MFLAB MEDICAL INSTRUMENTS CO., LTD.

NINGBO MFLAB MEDICAL INSTRUMENTS CO., LTD.

China · 宁波 · www.breathcare.cn
✓ Record-verifiedregistrations found in 10 marketsEU SRN CN-MF-000032006Unified social credit code 91330212573667646X

This company holds 5 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Singapore, South Korea, Australia, Israel — 9 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
5China registrations
Class I 1Class II 4
as of 2026-09-04
EUEuropean UnionEUDAMED
46UDI-DI device records
Class I 18Class IIa 28
USUnited StatesFDA openFDA
11listed device types
Class I 9Class II 2Class III 0
plus 11 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
39registered device records
Class I 14Class IIa 23IVD general 2
BRBrazilANVISA
33registered devices
Class I 5Class II 28
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
4registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
8active ARTG entries
IIa 8
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
15registrations
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 Union46 raw hits, 0 excluded, 46 confirmed
United States11 registration records, 0 510(k), 0 PMA
China5 certificates (Class III 0 / II 4 / I 1), as of 2026-09-04
United Kingdom39 confirmed, 0 excluded
Brazil33 confirmed, 0 excluded
Saudi Arabia4 confirmed, 0 excluded
Manufacturer names merged into this page: NINGBO MFLAB MEDICAL INSTRUMENTS CO., LTD. · NINGBO MFLAB MEDICAL INSTRUMENTS CO., LTD · NINGBO MFLAB (YINDONG) MEDICAL INSTRUMENTS CO., LTD · MFLAB (NINGBO) MEDICAL INSTRUMENT CO., LTD- · Ningbo MFLab Medical Instruments Co.Ltd · Ningbo MFLAB Medical Instruments Co., Ltd.

Regulatory identity

EU manufacturer SRN
CN-MF-000032006
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)
UK responsible person
SUNGO Certification Company Limited
Unified social credit code
91330212573667646X
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
166
Annual revenue
RMB 50–100M
Website
www.breathcare.cn
Product categories
呼吸、麻醉和急救器械手术器械临床检验器械及试剂

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Registration status
Active
Incorporated
2011-05-06
Registered capital
CNY 11,000,000
Paid-in capital
CNY 11,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2019-03-01
Recognitions
Micro and small enterpriseNational High-Tech Enterprise

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 listed device types

showing 8 of 11
Mask, Oxygen, Low Concentration, Venturi 1Mouthpiece, Breathing 1Container, Specimen, Sterile 1Mask, Oxygen, Non-Rebreathing 1Cannula, Nasal, Oxygen 1Mask, Oxygen 1Dish, Tissue Culture 1Airway, Oropharyngeal, Anesthesiology 1

Registration details (sample)

MarketIdentifierNameClass / date
CN浙械注准20182080481一次性使用雾化吸入器Class II
CN浙械注准20182080480一次性使用鼻氧管Class II
CN浙械注准20182080479一次性使用输氧面罩Class II
CN浙械注准20182020478一次性使用吸引管Class II
EU06971956730263Oral Pharyngeal AirwaysClass I
EU06971956739907Oral Pharyngeal AirwaysClass I
EU06971956739891Oral Pharyngeal AirwaysClass I
EU06971956739884Oral Pharyngeal AirwaysClass I
UK35142Nebulizer Masks for Single UseClass IIa
UK10749Suction CathetersClass IIa
UK37704Disposable Breathing circuitsClass IIa
BR10150470500Cateter Nasal para Oxigênio Tipo Óculos FoyomedClass II
BR10150470501Cânula de Guedel Estéril FoyomedClass I
BR10150470504Mascara para Traqueostomia FoyomedClass II
SAME0000007141SFDAA00001Breathwell Face Shield
SAME0000000300SFDAA00097MFLAB brand

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