HomeChinaNANJING SHUANGWEI BIOTECHNOLOGY CO., LTD.

NANJING SHUANGWEI BIOTECHNOLOGY CO., LTD.

China · 南京 · www.shuangweibio.com
✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000023311Unified social credit code 913201917260669735

This company holds 18 NMPA certificates in China and has registrations in European Union, United States, Brazil — 3 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
18China registrations
Class I 6Class II 7Class III 5
as of 2026-09-04
EUEuropean UnionEUDAMED
19UDI-DI device records
Class IIb 19
USUnited StatesFDA openFDA
1listed device types
Class I 0Class II 1Class III 0
plus 1 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
0registered devices
2 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
0valid device licences
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 Union19 raw hits, 0 excluded, 19 confirmed
United States1 registration records, 0 510(k), 0 PMA
China18 certificates (Class III 5 / II 7 / I 6), as of 2026-09-04
Manufacturer names merged into this page: NANJING SHUANGWEI BIOTECHNOLOGY CO., LTD. · NANJING SHUANGWEI BIOTECHNOLOGY CO. LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000023311
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Unified social credit code
913201917260669735
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
238
Annual revenue
RMB 100–500M
Website
www.shuangweibio.com
Product categories
输血及体外循环康复 & 养老医用耗材手术室及急救

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
2001-02-01
Registered capital
CNY 65,000,000
Paid-in capital
CNY 65,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Professional technical services
Last approval date
2025-11-06
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SMEPrivate technology enterpriseSRDI SMEInnovative SME

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 listed device types

Catheter, Ultrasound, Intravascular 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20253100665血浆病毒灭活设备Class III
CN国械注准20243101776一次性使用富血小板血浆制备套装Class III
CN国械注准20173100517一次性使用白细胞过滤输血器材Class III
CN国械注准20153140989创面封闭式负压引流套装Class III
EU06952320392003Class IIb
EU06952320392102Class IIb
EU06952320392201Class IIb
EU06952320392300Class IIb

Similar companies

Acoresmed Co., Ltd.
China · markets 1
Aimagine Care Technology Co., Ltd.
China · markets 2
Allmed Medical Products Co. Ltd.
China · markets 12
ALTON(shanghai)medical Instruments Co.,Ltd
China · markets 12
Ambulanc (Shenzhen) Tech. Co. Ltd.
China · markets 10
Andon Health Co., Ltd.
China · markets 10
Is this your company? Claim the page, add information or report a data error.Claim / report an error →