HomeChinaMEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.

MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.

China · 深圳
✓ Record-verifiedregistrations found in 13 marketsEU SRN CN-MF-000005925Unified social credit code 91440300573106363N

This company holds 176 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 12 overseas markets. EU UDI-DI records ≥243, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
176China registrations
Class I 12Class II 148Class III 16
as of 2026-09-04
EUEuropean UnionEUDAMED
≥243UDI-DI device records
Class I 6Class IIa 72Class IIb 38IVD A 45IVD B 2IVD C 80
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
1listed device types
Class I 1Class II 0Class III 0
plus 1 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
13registered device records
Class I 2Class IIa 3Class IIb 8
BRBrazilANVISA
24registered devices
Class I 2Class II 22
41 including historic records
SASaudi ArabiaSFDA
6registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
2valid device licences
Class I 2
SGSingaporeHSA SMDR
5device registrations
CLASS B 2CLASS C 3
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
10active ARTG entries
Class I 1IIb 9
HKHong KongMDACS
8valid listings
Class II 2Class III 6
ILIsraelAMAR
22registrations
RURussiaRoszdravnadzor
30active registrations
Class 2a 14Class 2b 15Class 3 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 Union2,061 raw hits, 57 excluded, 243 confirmed. Large result set — only the first 300 verified
United States1 registration records, 0 510(k), 0 PMA, 1 excluded
China176 certificates (Class III 16 / II 148 / I 12), as of 2026-09-04
United Kingdom13 confirmed, 1 excluded
Brazil24 confirmed, 1 excluded
Saudi Arabia6 confirmed, 0 excluded
Manufacturer names merged into this page: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. · MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD · Medcaptain Medical Technology Co., Ltd.

Regulatory identity

EU manufacturer SRN
CN-MF-000005925
EU authorised representative
R Sight B.V.
UK responsible person
Etheria Medical Ltd
Unified social credit code
91440300573106363N
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
713
Annual revenue
over RMB 500M
Product categories
医用耗材体外诊断输血、透析和体外循环器械手术器械呼吸、麻醉和急救器械注输、护理和防护器械

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
2011-04-26
Registered capital
CNY 499,716,086
Paid-in capital
CNY 195,726,000
Legal form
Joint-stock limited company (foreign-invested)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2026-07-13
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseAbove-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 listed device types

Device, Vein Location, Liquid Crystal 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20263221033全自动血型分析仪Class III
CN国械注准20263080554麻醉系统Class III
CN国械注准20253222577全自动血型分析仪Class III
CN国械注准20253081888麻醉机Class III
EU06926802612293Fully Automated Blood Grouping SystemIVD A
EU06926802602904Class IIb
EU06926802612286Fully Automated Blood Grouping SystemIVD A
EU06926802609927Class IIa
UK47769Anesthesia SystemClass IIb
UK13215BD neXus DClass IIb
UK13215Medcaptain, BD neXus DClass IIb
BR81504790518Vestuário para compressão dos membrosClass I
BR81504799244Bomba preventiva de DVTClass II
BR81504799247Endoscópio do Trato Gastrointestinal InferiorClass II
SAME0000015363SFDAA00011Video Laryngoscope
SAME0000000173SFDAA00001Vein Illuminator

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