HomeChinaZhejiang Sorfa Life Science Research Co., Ltd

Zhejiang Sorfa Life Science Research Co., Ltd

China · 湖州 · www.biosorfa.com
✓ Record-verifiedregistrations found in 3 marketsEU SRN CN-MF-000012276Unified social credit code 91330500796463077G

This company has registrations in European Union, United States, Israel — 3 overseas markets. No China NMPA registrations were found.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
0China registrations
as of 2026-09-01
EUEuropean UnionEUDAMED
6UDI-DI device records
Class I 1IVD A 5
USUnited StatesFDA openFDA
9listed device types
Class I 9Class II 0Class III 0
plus 9 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
0registered devices
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
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 Union6 raw hits, 0 excluded, 6 confirmed
United States9 registration records, 0 510(k), 0 PMA
China0 certificates (Class III 0 / II 0 / I 0), as of 2026-09-01
Manufacturer names merged into this page: Zhejiang Sorfa Life Science Research Co., Ltd.

Regulatory identity

EU manufacturer SRN
CN-MF-000012276
EU authorised representative
SUNGO Europe B.V.
Unified social credit code
91330500796463077G
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
218
Annual revenue
RMB 100–500M
Website
www.biosorfa.com
Product categories
体外诊断临床检验器械及试剂

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
2006-12-04
Registered capital
CNY 66,150,000
Paid-in capital
CNY 66,150,000
Legal form
Joint-stock limited company (unlisted)
Industry classification
Research and experimental development
Last approval date
2026-08-11
Recognitions
National High-Tech EnterpriseTechnology-based SMESRDI SMEAbove-designated-size industrial enterprise
Listing
Listed on 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 listed device types

showing 8 of 9
Container, Specimen Mailer And Storage, Sterile 1Container, Specimen, Sterile 1Container, Specimen, Urine, Drugs Of Abuse, Over The Counter 1Micro Pipette 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Dish, Tissue Culture 1Container, Specimen Mailer And Storage, Non-Sterile 1Applicator, Absorbent Tipped, Non-Sterile 1

Registration details (sample)

MarketIdentifierNameClass / date
EU06975474370406Class I
EU06975474370338IVD A
EU06975474370291IVD A
EU06975474370208IVD A

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 →