HomeChinaGuangzhou AMK Medical Equipment Co.,Ltd

Guangzhou AMK Medical Equipment Co.,Ltd

China · 广州 · 2208295030.p.make.dcloud.portal1.portal.thef
✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000045752Unified social credit code 914401013314799257

This company holds 7 NMPA certificates in China and has registrations in European Union, United States, Brazil — 3 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
7China registrations
Class I 5Class II 2
as of 2026-09-04
EUEuropean UnionEUDAMED
6UDI-DI device records
Class I 6
USUnited StatesFDA openFDA
10listed device types
Class I 9Class II 1Class III 0
plus 10 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
4registered devices
Class I 1Class II 3
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 Union6 raw hits, 0 excluded, 6 confirmed
United States10 registration records, 0 510(k), 0 PMA
China7 certificates (Class III 0 / II 2 / I 5), as of 2026-09-04
United Kingdom0 confirmed, 1 excluded
Brazil4 confirmed, 0 excluded
Manufacturer names merged into this page: GUANGZHOU AMK MEDICAL EQUIPMENT CO.,LTD. · GUANGZHOU AMK MEDICAL EQUIPMENT CO., LTD. · GUAGZHOU AMK MEDICAL EQUIPMENT CO.,LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000045752
EU authorised representative
MedPath GmbH
Unified social credit code
914401013314799257
Exhibition record
CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
17
Annual revenue
RMB 10–30M
Website
2208295030.p.make.dcloud.portal1.portal.thef
Product categories
呼吸、麻醉和急救器械

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
2015-04-16
Registered capital
CNY 16,419,229
Paid-in capital
CNY 10,280,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2026-03-18
Recognitions
Micro and small enterpriseNational High-Tech Enterprise

Business registration data from Tianyancha, as of 2026-09-03. 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 10
Laryngoscope, Rigid 1Cannula, Nasal, Oxygen 1Device, Fixation, Tracheal Tube 1Bag, Reservoir 1Washer Of Body Waste Receptacles 1Airway, Oropharyngeal, Anesthesiology 1Airway, Nasopharyngeal 1Catheters, Suction, Tracheobronchial 1

Registration details (sample)

MarketIdentifierNameClass / date
CN粤械注准20182080009一次性使用密闭式吸痰导管Class II
CN粤械注准20172080258一次性使用气管插管Class II
CN粤穗械备20230572气管插管固定器Class I
CN粤穗械备20220846鼻氧管Class I
EU06972444528393Anesthesia reservoir bagClass I
EU06972444528386Anesthesia reservoir bagClass I
EU06972444528379Anesthesia reservoir bagClass I
EU06972444528362Anesthesia reservoir bagClass I
BR81760450001Bolsa Pressórica Net FuserClass I
BR81521809001Tubo Endotraqueal LaserClass II
BR80722800018Sonda de Aspiração Sistema Fechado DBI MedicalClass II

Similar companies

Acoresmed Co., Ltd.
China · markets 1
Aimagine Care Technology Co., Ltd.
China · markets 2
Allmed Medical Products Co. Ltd.
China · markets 12
ALTON(shanghai)medical Instruments Co.,Ltd
China · markets 12
Ambulanc (Shenzhen) Tech. Co. Ltd.
China · markets 10
Andon Health Co., Ltd.
China · markets 10
Is this your company? Claim the page, add information or report a data error.Claim / report an error →