HomeChinaROOSIN MEDICAL CO.,LTD

ROOSIN MEDICAL CO.,LTD

China · Taizhou Jiangsu · www.roosin.com
✓ Record-verifiedregistrations found in 10 marketsEU SRN CN-MF-000021163Unified social credit code 9132120070397010XM

This company holds 24 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Canada, Singapore, Australia, Israel, Russia — 9 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
24China registrations
Class I 13Class II 7Class III 4
as of 2026-09-04
EUEuropean UnionEUDAMED
103UDI-DI device records
Class I 6Class IIa 46Class IIb 51
USUnited StatesFDA openFDA
9listed device types
Class I 7Class II 0Class III 0unclassified 2
plus 13 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
11registered device records
Class I 2Class IIa 5Class IIb 4
BRBrazilANVISA
3registered devices
Class II 3
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
4 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
5active ARTG entries
IIa 4IIb 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
8registrations
RURussiaRoszdravnadzor
1active registrations
Class 3 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 Union103 raw hits, 0 excluded, 103 confirmed
United States13 registration records, 6 510(k), 0 PMA
China24 certificates (Class III 4 / II 7 / I 13), as of 2026-09-04
United Kingdom11 confirmed, 0 excluded
Brazil3 confirmed, 0 excluded
Manufacturer names merged into this page: Roosin Medical Co., Ltd. · ROOSIN MEDICAL CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000021163
EU authorised representative
Prolinx GmbH
UK responsible person
SUNGO Certification Company Limited
Unified social credit code
9132120070397010XM
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Taizhou Jiangsu
Social-insurance enrolees
166
Annual revenue
RMB 50–100M
Website
www.roosin.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.

Business registration

Registration status
Active
Incorporated
1996-11-27
Registered capital
CNY 32,140,000
Paid-in capital
CNY 13,000,000
Legal form
Joint-stock limited company (unlisted, natural-person invested or controlled)
Industry classification
Pharmaceutical manufacturing
Last approval date
2026-01-28
Recognitions
Micro and small enterpriseNational High-Tech EnterprisePrivate technology enterpriseNational SRDI "Little Giant"Recognised enterprise technology centreTorch Programme enterpriseAbove-designated-size industrial enterprise
Listing
Delisted 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

12015 · K143335
12019 · K181478
12023 · K230190
12024 · K231088
22026 · K254034

FDA listed device types

showing 8 of 9
Dressing, Wound, Drug 1Wound Dressing With Animal-Derived Material(S) 1Bandage, Liquid, Skin Protectant 1Holder, Ureteral Catheter 1System, Blood Collection, Vacuum-Assisted, Manual 1Device, Intravascular Catheter Securement 1Dressing, Wound, Hydrophilic 1Dressing, Wound, Hydrogel Without Drug And/Or Biologic 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20243140020聚氨酯泡沫敷料Class III
CN国械注准20223141641水胶体油纱Class III
CN国械注准20183140461医用水胶体敷料Class III
CN国械注准20173143100海藻酸钙敷料Class III
EU16958868780095Class IIb
EU16958868780064Class IIb
EU26958868783109Class IIa
EU26958868785042Cutiderm Foam Dressing 15x15cm - Box of 5Class IIa
UK34864Sterile DressingsClass I
UK47694Sterile Burn GelClass IIb
UK43186Hydrophilic-Gel Exudate-Absorbent DressingClass IIb
USK254034Roosin Collagen Powder2026-06-03
USK253974Roosin Collagen Dressing2026-06-03
USK231088Copper Foam Dressing (Prescription and OTC)2024-01-11
BR81693529002BURN CARE - GEL PARA ALÍVIO DE QUEIMADURASClass II
BR82956209002BURN CARE - GEL PARA ALÍVIO DE QUEIMADURASClass II
BR80896510001HIBECOL - CURATIVO HIDROCOLÓIDEClass II

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