HomeChinaSuZhou AND Science & Technology Development Corporation

SuZhou AND Science & Technology Development Corporation

China · 苏州 · www.andtosi.com
✓ Record-verifiedregistrations found in 4 marketsUnified social credit code 91320500785592826U

This company holds 167 NMPA certificates in China and has registrations in United States, Brazil, Russia — 3 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
167China registrations
Class I 103Class II 34Class III 30
as of 2026-09-04
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
9listed device types
Class I 6Class II 3Class III 0
plus 11 registration records and 12 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
12registered devices
Class I 6Class II 6
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
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
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 Union6,794 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified
United States11 registration records, 12 510(k), 0 PMA, 295 excluded
China167 certificates (Class III 30 / II 34 / I 103), as of 2026-09-04
United Kingdom0 confirmed, 41 excluded
Brazil12 confirmed, 48 excluded
Saudi Arabia0 confirmed, 8 excluded
Canada0 confirmed, 17 excluded
Manufacturer names merged into this page: SUZHOU AND SCIENCE & TECHNOLOGY DEVELOPMENT CORP. · SUZHOU HVHA MEDICAL TECHNOLOGY DEVELOPMENT CO., LTD. · SuZhou AND Science & technology Development CO., Ltd.

Regulatory identity

Unified social credit code
91320500785592826U
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
341
Annual revenue
RMB 100–500M
Website
www.andtosi.com
Product categories
高值耗材医用耗材手术室及急救植入器械

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
2006-03-30
Registered capital
CNY 118,123,046
Paid-in capital
CNY 118,123,046
Legal form
Joint-stock limited company (listed, natural-person invested or controlled)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2026-04-02
Recognitions
National High-Tech EnterprisePrivate technology enterpriseGazelle enterpriseRecognised enterprise technology centreAbove-designated-size industrial enterprise
Listing
Listed on the A-share marketDelisted from the NEEQ

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

61983 · K832090
31984 · K843617
12009 · K083817
12013 · K121925
12026 · K253080

FDA listed device types

showing 8 of 9
Template 1Pack, Hot Or Cold, Disposable 1Orthopedic Manual Surgical Instrument 1Fiber, Medical, Absorbent 1Bandage, Elastic 1Bandage, Liquid, Skin Protectant 1Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Screw, Fixation, Bone 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20253141234聚氨酯封闭式负压引流材料Class III
CN国械注准20253132537半月板缝合系统Class III
CN国械注准20253131652HA涂层金属骨针Class III
CN国械注准20253130998聚醚醚酮带线锚钉Class III
USK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)2026-06-18
USK121925POWDERED LATEX SURGEON'S GLOVE2013-08-28
USK083817M. DIOR BRAND2009-09-16
BR80454380110Kit Instrumental Endoscópico UBE -ORTOSPINEClass I
BR10446519001PERFURADOR ORTOPÉDICO E SERRA ORTOPÉDICA 8 SERIESClass II
BR81189669016Kit Vertemax UNOClass II

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