HomeChinaWuxi Tongda Medical Electrical Appliance Co., Ltd.

Wuxi Tongda Medical Electrical Appliance Co., Ltd.

China · 无锡市 · www.tongdame.com
✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000027398Unified social credit code 91320200741307958K

This company holds 8 NMPA certificates in China and has registrations in European Union, Brazil, Saudi Arabia — 3 overseas markets. EU UDI-DI records ≥176, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
8China registrations
Class I 1Class II 3Class III 4
as of 2026-09-04
EUEuropean UnionEUDAMED
≥176UDI-DI device records
Class I 19Class IIa 157
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
4registered devices
Class II 4
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
4registered 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 Union216 raw hits, 24 excluded, 176 confirmed. Large result set — only the first 300 verified
United States0 registration records, 0 510(k), 0 PMA, 3 excluded
China8 certificates (Class III 4 / II 3 / I 1), as of 2026-09-04
Brazil4 confirmed, 2 excluded
Saudi Arabia4 confirmed, 3 excluded
Manufacturer names merged into this page: CHANGZHOU TONGDA MEDICAL APPLIANCE CO. LTD · CHANGZHOU TONGDA MEDICAL APPLIANCE CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000027398
EU authorised representative
Caretechion GmbH
Unified social credit code
91320200741307958K

Company information

Country
China
Social-insurance enrolees
7
Website
www.tongdame.com

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
2002-07-31
Registered capital
CNY 3,000,000
Paid-in capital
CNY 3,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2023-03-10
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.

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20193141974一次性使用输注泵Class III
CN国械注准20173030908一次性使用中心静脉导管包Class III
CN国械注准20163142045一次性使用胸穿包Class III
CN国械注准20163082046一次性使用麻醉穿刺包Class III
EU06945632025059BIOSAFEClass IIa
EU06945632025066BIOSAFEClass IIa
EU06945632023062XINLIClass IIa
EU06945632023055XINLIClass IIa
BR81359809003ESCALPE DESCARTÁVELClass II
BR80194139005EQUIPOS DE INFUSAO GRAVITACIONAL COM BURETA BR DECClass II
BR81359809004Equipos de infusão gravitacional intravenosa estéril e de uso único - Class II
SAME0000010314SFDAA00003commode chair
SAME0000010314SFDAA00004walking aid

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