HomeChinaSuzhou Sunmed Co., Ltd

Suzhou Sunmed Co., Ltd

China · Suzhou · www.szsunmed.com
✓ Record-verifiedregistrations found in 9 marketsEU SRN CN-MF-000010170

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Taiwan, Australia, Israel, Russia — 9 overseas markets. EU UDI-DI records ≥224, 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
≥224UDI-DI device records
Class I 216Class IIa 8
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
28listed device types
Class I 26Class II 0Class III 0unclassified 2
plus 28 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
72registered device records
Class I 59Class IIa 11System or Procedure Pack 2
BRBrazilANVISA
26registered devices
Class I 25Class II 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
22registered 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
14active ARTG entries
Class I 6IIa 2Class Is (sterile) 6
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
8registrations
RURussiaRoszdravnadzor
2active registrations
Class 1 2
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 Union948 raw hits, 76 excluded, 224 confirmed. Large result set — only the first 300 verified
United States28 registration records, 0 510(k), 0 PMA, 9 excluded
United Kingdom72 confirmed, 2 excluded
Brazil26 confirmed, 2 excluded
Saudi Arabia22 confirmed, 2 excluded
Canada0 confirmed, 3 excluded
Manufacturer names merged into this page: SUZHOU SUNMED CO., LTD · SUZHOU SUNMED CO, LTD · Suzhou Sunmed Co., Ltd · Suzhou Sunmed Co LTD · Suzhou Sunmed Co. Ltd. · Suzhou Sunmed Co,Ltd

Regulatory identity

EU manufacturer SRN
CN-MF-000010170
EU authorised representative
SUNGO Europe B.V.
UK responsible person
MT Promedt Consulting Ltd

Company information

Country
China
City
Suzhou
Website
www.szsunmed.com
Product categories
Integrated Care, Rehabilitation & HomecareConsumables, disposables & infection control

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 listed device types

showing 8 of 28
Gauze / Sponge,Nonresorbable For External Use 1Splint, Hand, And Components 1First Aid Kit Without Drug 1Insoles, Medical 1Bedding, Disposable, Medical 1Orthosis, Limb Brace 1Finger Cot 1Bag, Ice 1

Registration details (sample)

MarketIdentifierNameClass / date
EU06973864850071SGS5X5-12 Gauze swab sterile, 5pcs/pack, 20packs/boxClass I
EU06973864856813SGS10X20-16X/10 STERILE X-RAY GAUZE SWAB 10X20CM X16PLY PACK OF 10 DOUBLE WRAPPEDClass I
EU06973864856806SGS10X20-16X/10 STERILE X-RAY GAUZE SWAB 10X20CM X16PLY PACK OF 10 DOUBLE WRAPPEDClass I
EU06973864851122LAP30X30-12X/5DP Sterile gauze swabs 30X30cm 12ply Xray pack of 5pcs double wrappedClass I
UK46967Cuffed ET TubeClass I
UK58095Arterial Blood Gas Sryines with NeedleClass IIa
UK37591SuperNO2VA Et Mask, Adult LargeClass IIa
BR81602800016Seringa Nasal Multi SaúdeClass I
BR80718470040EVO TAPE COESIVA LClass I
BR80718479001BANDAGEM ISRAELENSE DE EMERGÊNCIA - EVO TAPEClass II
SAME0000009200SFDAA00001PHMCO Disposable Under pad Adult
SAME0000019197SFDAA00001NobleMed Kinesiology Tape

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