HomeChinaJiangsu Suyun Medical Materials Co., Ltd

Jiangsu Suyun Medical Materials Co., Ltd

China · Lianyungang Jiangsu · www.suyunmedical.com
✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000021132

This company has registrations in European Union, United States, Brazil, Taiwan, South Korea, Australia, Israel, Russia — 8 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
pendingnot queried
EUEuropean UnionEUDAMED
≥300UDI-DI device records
Class I 121Class IIa 179
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
11listed device types
Class I 4Class II 7Class III 0
plus 12 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
7registered devices
Class I 7
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
3valid device licences
Class II 3
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Business type not stated 1Import 1
AUAustraliaTGA ARTG
5active ARTG entries
Class I 4Class Is (sterile) 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
6registrations
RURussiaRoszdravnadzor
19active registrations
Class 1 13Class 2a 6
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 Union1,213 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified
United States12 registration records, 3 510(k), 0 PMA
Brazil7 confirmed, 0 excluded
Manufacturer names merged into this page: JIANGSU SUYUN MEDICAL MATERIALS CO., LTD. · JIANGSU SUYUN MEDICAL MATERIALS CO. LTD · JIANGSU SUYUN MEDICAL MATERIALS CO. LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000021132
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)

Company information

Country
China
City
Lianyungang Jiangsu
Website
www.suyunmedical.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesWomen’s Health, Neonatology & Pediatric CareObstetrics & gynaecology

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.

FDA 510(k) clearances by year

12011 · K102847
12021 · K210914
12022 · K202437

FDA listed device types

showing 8 of 11
Spatula, Cervical, Cytological 1System, Abortion, Vacuum 1Clamp, Umbilical 1Collector, Urine, (And Accessories) For Indwelling Catheter 1Curette, Suction, Endometrial (And Accessories) 1Catheter, Coude 1Catheter, Straight 1Sound, Uterine 1

Registration details (sample)

MarketIdentifierNameClass / date
EU26933298294838Class IIa
EU26933298294821Class IIa
EU26933298294814Class IIa
EU26933298294807Class IIa
USK202437Infusion Sets for Single Use2022-03-25
USK210914Sterile Syringe for Single Use2021-12-17
USK102847DISPOSABLE ENDOMETRIAL SUCTION CURETTE2011-04-14
BR80884880010FAMÍLIA SWAB PARA COLETA DE AMOSTRASClass I
BR10379860103SWAB PARA COLETA DE AMOSTRAS ESTÉRILClass I
BR10379860048ESCOVA CERVICAL ESTÉRILClass I

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