HomeChinaHeFei Breath Medical Co.,Ltd

HeFei Breath Medical Co.,Ltd

China · 合肥 · www.breathbest.com
✓ Record-verifiedregistrations found in 1 marketsUnified social credit code 91340100MA2W27X93E

This company holds 69 NMPA certificates in China.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
69China registrations
Class I 52Class II 15Class III 2
as of 2026-09-04
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
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
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.

European Union53 raw hits, 53 excluded, 0 confirmed
United States0 registration records, 0 510(k), 0 PMA, 2 excluded
China69 certificates (Class III 2 / II 15 / I 52), as of 2026-09-04
United Kingdom0 confirmed, 4 excluded
Brazil0 confirmed, 1 excluded

Regulatory identity

Unified social credit code
91340100MA2W27X93E
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
133
Annual revenue
RMB 50–100M
Website
www.breathbest.com
Product categories
注输、护理和防护器械呼吸、麻醉和急救器械手术器械植入器械

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
2020-07-29
Registered capital
CNY 13,049,420
Paid-in capital
CNY 13,049,420
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Research and experimental development
Last approval date
2024-03-29
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseInnovative SME

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.

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20263131009鼻中隔可吸收钉固定器Class III
CN国械注准20253140731可降解耳鼻止血绵Class III
CN皖械注准20252140125鼓膜通气引流管Class II
CN皖械注准20232140148液体敷料Class II

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