HomeChinaChangzhou Medical Bioengineering Co., Ltd

Changzhou Medical Bioengineering Co., Ltd

China · 常州 · www.china-changsheng.com
✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000026604Unified social credit code 913204021372045225

This company holds 16 NMPA certificates in China and has registrations in European Union, Brazil, Saudi Arabia, Taiwan — 4 overseas markets. EU UDI-DI records ≥40, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
16China registrations
Class I 1Class II 13Class III 2
as of 2026-09-04
EUEuropean UnionEUDAMED
≥40UDI-DI device records
Class IIa 38Class IIb 2
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
0registered device records
BRBrazilANVISA
1registered devices
Class II 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
1valid device licences
Class II 1
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 Union737 raw hits, 260 excluded, 40 confirmed. Large result set — only the first 300 verified
United States0 registration records, 0 510(k), 0 PMA, 7 excluded
China16 certificates (Class III 2 / II 13 / I 1), as of 2026-09-04
United Kingdom0 confirmed, 1 excluded
Brazil1 confirmed, 2 excluded
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: Changzhou Medical Bioengineering Co. Ltd. · CHANGZHOU MEDICAL BIOENGINEERING CO.,LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000026604
EU authorised representative
SUNGO Europe B.V.
Unified social credit code
913204021372045225
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
27
Annual revenue
RMB 30–50M
Website
www.china-changsheng.com
Product categories
手术器械医用耗材手术室及急救注输、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
1997-06-16
Registered capital
CNY 5,180,000
Paid-in capital
CNY 5,180,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Wholesale trade
Last approval date
2025-05-06
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20173144442一次性使用输注泵Class III
CN国械注准20173084441一次性使用麻醉穿刺包Class III
CN苏械注准20252021869一次性使用穿刺缝合套装Class II
CN苏械注准20252020941一次性使用皮肤缝合器Class II
EU06956862090137CYSClass IIb
EU06956862090144CYSClass IIb
EU06956862016021CYSClass IIa
EU06956862016199CYSClass IIa
BR10289680148Bomba de infusão intravenosa elastomérica CS MedicalClass II
SAME0000014445SFDAA00001Disposable Breast Pads

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