Home›China›BONREE MEDICAL CO., LTD.

BONREE MEDICAL CO., LTD.

China · Zhongshan Guangdong · www.bonreemed.com

✓ Record-verifiedregistrations found in 11 marketsEU SRN CN-MF-000017844Unified social credit code 91442000MA4UK9PR59

This company holds 29 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 10 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually.

Registrations by market

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

CNChinaNMPA

29China registrations

Class I 2Class II 27

as of 2026-09-04

EUEuropean UnionEUDAMED

≥300UDI-DI device records

Class I 3Class IIa 280Class IIb 17

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

USUnited StatesFDA openFDA

11listed device types

Class I 8Class II 3Class III 0

plus 11 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

32registered device records

Class I 5Class IIa 27

BRBrazilANVISA

15registered devices

Class II 15

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

5valid device licences

Class I 3Class II 2

SGSingaporeHSA SMDR

4device registrations

CLASS B 3CLASS C 1

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

13active ARTG entries

Class I 2IIa 9IIb 1Class Is (sterile) 1

HKHong KongMDACS

3valid listings

Class II 3

ILIsraelAMAR

5registrations

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 Union620 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States11 registration records, 1 510(k), 0 PMA

China29 certificates (Class III 0 / II 27 / I 2), as of 2026-09-04

United Kingdom32 confirmed, 0 excluded

Brazil15 confirmed, 0 excluded

Manufacturer names merged into this page: BONREE MEDICAL CO., LTD · BONREE MEDICAL CO. LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000017844
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
UK responsible person: SUNGO Certification Company Limited
Unified social credit code: 91442000MA4UK9PR59
Exhibition record: CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Business registration

Registration status: Active
Incorporated: 2015-12-04
Registered capital: CNY 6,000,000
Paid-in capital: CNY 6,000,000
Legal form: Limited liability company (natural-person invested or controlled)
Industry classification: Pharmaceutical manufacturing
Last approval date: 2024-01-09
Recognitions: Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SMESRDI SMEAbove-designated-size industrial 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 510(k) clearances by year

12022 · K212430

FDA listed device types

showing 8 of 11

Tube, Aspirating, Flexible, Connecting 1Catheter And Tip, Suction 1Apparatus, Suction, Operating-Room, Wall Vacuum Powered 1Stylet, Tracheal Tube 1Mask, Oxygen, Non-Rebreathing 1System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile 1Cannula, Nasal, Oxygen 1Mask, Oxygen 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	粤械注准20232140335	一次性使用输尿管球囊扩张导管套件	Class II
CN	粤械注准20232080195	一次性使用带吸痰腔气管插管	Class II
CN	粤械注准20232080108	一次性无菌双腔支气管插管套件	Class II
CN	粤械注准20222140476	一次性使用胃管	Class II
EU	06942382601106	INSPIRATION Medical Tracheostomy Masks	Class IIa
EU	06942382601113	INSPIRATION Medical Tracheostomy Masks	Class IIa
EU	06942382611341	BM 100% Silicone Foley Catheters	Class IIb
EU	06942382600642	BM Closed Suction System	Class IIa
UK	10749	Suction Catheter (Mucus Suction Catheter included)	Class IIa
UK	46232	Disposable Air Cushion Face Masks	Class IIa
UK	37469	Intubating Stylet	Class IIa
US	K212430	BONREE Nelaton Catheter	2022-04-29
BR	10369460202	SONDA GÁSTRICA LEVINE SOLIDOR®	Class II
BR	10369469032	MASCARA LARÍNGEA REUTILIZÁVEL SOLIDOR®	Class II
BR	10369460214	SONDA RETAL SOLIDOR®	Class II