Home›China›Guangzhou Berrcom Medical Device Co.,Ltd

Guangzhou Berrcom Medical Device Co.,Ltd

China · Guangzhou · www.berrcomhealth.com

✓ Record-verifiedregistrations found in 13 marketsEU SRN CN-MF-000013852Unified social credit code 91440115718185809W

This company holds 12 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 12 overseas markets.

Registrations by market

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

CNChinaNMPA

12China registrations

Class I 1Class II 11

as of 2026-09-04

EUEuropean UnionEUDAMED

129UDI-DI device records

Class IIa 129

USUnited StatesFDA openFDA

7listed device types

Class I 3Class II 4Class III 0

plus 8 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

6registered device records

Class I 2Class IIa 4

BRBrazilANVISA

3registered devices

Class II 3

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

2registered imported devices

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

CACanadaMDALL

0active device licences

9 including historic records

TWTaiwanTFDA

3valid device licences

Class II 3

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

21active ARTG entries

Class I 2IIa 19

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

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 Union129 raw hits, 0 excluded, 129 confirmed

United States8 registration records, 6 510(k), 0 PMA

China12 certificates (Class III 0 / II 11 / I 1), as of 2026-09-04

United Kingdom6 confirmed, 0 excluded

Brazil3 confirmed, 0 excluded

Saudi Arabia2 confirmed, 0 excluded

Manufacturer names merged into this page: Guangzhou Berrcom Medical Device Co., Ltd · GUANGZHOU BERRCOM MEDICAL DEVICE CO., LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000013852
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
UK responsible person: SHARE INFO LTD
Unified social credit code: 91440115718185809W
Exhibition record: CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Business registration

Registration status: Active
Incorporated: 2000-01-11
Registered capital: CNY 111,111,100
Paid-in capital: CNY 30,000,000
Legal form: Limited liability company
Industry classification: Special-purpose equipment manufacturing
Last approval date: 2026-07-17
Recognitions: National High-Tech EnterpriseTechnology-based SMESRDI SMEInnovative 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.

FDA 510(k) clearances by year

12019 · K191570

42022 · K213746

12023 · K214077

FDA listed device types

Irrigator, Powered Nasal 1Polymer Patient Examination Glove 1Catheters, Suction, Tracheobronchial 1Oximeter 1Clinical Electronic Thermometer 1Oximeter, Infrared, Sporting, Aviation 1System, Measurement, Blood-Pressure, Non-Invasive 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	粤械注准20262080600	一次性使用雾化器	Class II
CN	粤械注准20252090295	电动吸鼻器	Class II
CN	粤械注准20252080069	网式雾化器	Class II
CN	粤械注准20232071528	贴片式体温计	Class II
EU	06947656119103	iTherm One	Class IIa
EU	06947656119110	aekrey	Class IIa
EU	06947656118946	ONE MEDICAL	Class IIa
EU	06947656119004	Optimal	Class IIa
UK	63711	Ear Thermometer	Class IIa
UK	17888	Non-contact Infrared Thermometer	Class IIa
UK	14035	Digital Basal Thermometer	Class IIa
US	K214077	Digital Thermometer, Model: DT007, DT008	2023-01-20
US	K213746	Digital thermometer, Model DT101, DT102	2022-04-05
US	K213084	Ear Thermometer, Model ET005, ET008, ET009	2022-02-25
BR	80112559006	Termômetro digital NEVONI	Class II
BR	10424969007	TERMOMETRO DIGITAL INFRAVERMELHO SEM CONTATO	Class II
BR	10424960011	TERMÔMETRO DIGITAL INFRAVERMELHO SEM CONTATO	Class II
SA	ME0000012480SFDAA00001	Fresh Nose	—
SA	ME0000012480SFDAA00001	Fresh Nose	—