HomeChinaSURGAID MEDICAL (XIAMEN) CO., LTD.

SURGAID MEDICAL (XIAMEN) CO., LTD.

China · 厦门 · www.surgaid.com
✓ Record-verifiedregistrations found in 9 marketsEU SRN CN-MF-000022724Unified social credit code 91350205562828483N

This company holds 97 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, South Korea, Australia, Russia — 8 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
97China registrations
Class I 26Class II 61Class III 10
as of 2026-09-04
EUEuropean UnionEUDAMED
110UDI-DI device records
Class IIa 110
USUnited StatesFDA openFDA
2listed device types
Class I 2Class II 0Class III 0
plus 2 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
8registered device records
Class IIa 5Class IIb 3
BRBrazilANVISA
16registered devices
Class II 16
17 including historic records
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 II 5
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Business type not stated 1
AUAustraliaTGA ARTG
6active ARTG entries
IIa 3IIb 3
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
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 Union110 raw hits, 0 excluded, 110 confirmed
United States2 registration records, 0 510(k), 0 PMA
China97 certificates (Class III 10 / II 61 / I 26), as of 2026-09-04
United Kingdom8 confirmed, 0 excluded
Brazil16 confirmed, 0 excluded
Manufacturer names merged into this page: SURGAID MEDICAL (XIAMEN)CO.,LTD. · SURGAID MEDICAL (XIAMEN) CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000022724
EU authorised representative
Lotus NL B.V.
UK responsible person
Amstermed UK Ltd
Unified social credit code
91350205562828483N
Exhibition record
CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
559
Annual revenue
RMB 100–500M
Website
www.surgaid.com
Product categories
手术器械医用成像器械

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
2010-11-23
Registered capital
CNY 10,000,000
Paid-in capital
CNY 1,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2023-08-14
Recognitions
National 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

Hook, Surgical, General & Plastic Surgery 1Retractor 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20263010755一次性使用胸腹腔镜高频手术器械Class III
CN国械注准20253012360一次性使用电动直线型切割吻合器Class III
CN国械注准20253011390一次性使用胸腹腔内窥镜高频手术器械Class III
CN国械注准20243022063可吸收结扎夹Class III
EU06926742056294Single Use Sterile RetractorClass IIa
EU06926742065197Single Use Endoscopic Linear Cutter StaplerClass IIa
EU06926742065180Single Use Endoscopic Linear Cutter StaplerClass IIa
EU06926742065173Single Use Endoscopic Linear Cutter StaplerClass IIa
UK63228Single Use Circumcision StaplerClass IIa
UK59871Single Use Sterile Endoscopic Cutter Stapler SetClass IIb
UK46737Single Use Sterile Anorectal Circular Stapler SetClass IIb
BR82070439001ENDOBAG LAPAROSCOPICA DESCARTAVEL PMED SURGICALClass II
BR82070439002CANULA DE ACESSO DESCARTÁVEL PMED SURGICALClass II
BR82070439003RETRATOR DE INCISÃO DESCARTÁVEL PMED SURGICALClass II

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