HomeChinaSURGIKARE

SURGIKARE

China · 上海 · www.surgicalinstruments.cn
✓ Record-verifiedregistrations found in 5 marketsUnified social credit code 91310107687333791Y

This company has registrations in United States, United Kingdom, Brazil, Taiwan, Australia — 5 overseas markets. No China NMPA registrations were found.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
0China registrations
as of 2026-09-01
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
44listed device types
Class I 44Class II 0Class III 0
plus 44 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
39registered device records
Class I 29Class IIa 8Class IIb 2
BRBrazilANVISA
10registered devices
Class I 10
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
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
IIa 2
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.

United States44 registration records, 0 510(k), 0 PMA
China0 certificates (Class III 0 / II 0 / I 0), as of 2026-09-01
United Kingdom39 confirmed, 0 excluded
Brazil10 confirmed, 0 excluded
Manufacturer names merged into this page: SURGIKARE

Regulatory identity

UK responsible person
GTS UK Healthcare
Unified social credit code
91310107687333791Y
Exhibition record
CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
Social-insurance enrolees
7
Annual revenue
RMB 50–100M
Website
www.surgicalinstruments.cn
Product categories
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
2009-04-07
Registered capital
CNY 2,000,000
Paid-in capital
CNY 500,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Wholesale trade
Last approval date
2024-10-11
Recognitions
Micro and small 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

showing 8 of 44
Forceps 1Gouge, Surgical, General & Plastic Surgery 1Probe 1Scissors, Orthopedic, Surgical 1Syringe, Ent 1Handle, Scalpel 1Elevator, Surgical, Dental 1Articulators 1

Registration details (sample)

MarketIdentifierNameClass / date
UK63656Abdominal/ENT/orthopaedic surgical probe, single-useClass I
UK64262curetteClass IIa
UK63975Dental anaesthesia syringe, single-useClass I
BR81504790081INSTRUMENTOS CIRURGICOS PARA UROLOGIA SURGIKAREClass I
BR81504790082INSTRUMENTOS CIRURGICOS PARA PODOLOGIA SURGIKAREClass I
BR81504790083Martelo de PercussãoClass I

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