HomeChinaHANGZHOU SINGCLEAN MEDICAL PRODUCTS CO., LTD

HANGZHOU SINGCLEAN MEDICAL PRODUCTS CO., LTD

China · Hangzhou Zhejiang · www.singclean.net
✓ Record-verifiedregistrations found in 9 marketsEU SRN CN-MF-000014098Unified social credit code 91330101747181911R

This company holds 23 NMPA certificates in China and has registrations in European Union, United Kingdom, Brazil, Singapore, South Korea, Australia, Hong Kong, Russia — 8 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
23China registrations
Class II 8Class III 15
as of 2026-09-04
EUEuropean UnionEUDAMED
298UDI-DI device records
Class IIa 3Class IIb 6Class III 115IVD B 47IVD general 120ivd-devices-self-testing 7
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
19registered device records
Class IIa 3Class IIb 2Class III 7IVD B 1IVD general 1Class B – Self-testing or Near-patient Testing 1IVD Devices for Self-Testing 4
BRBrazilANVISA
5registered devices
Class II 5
27 including historic records
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
3device registrations
CLASS B 1CLASS D 2
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
1active ARTG entries
Class III 1
HKHong KongMDACS
1valid listings
Class III 1
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
3active registrations
Class 3 3
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 Union298 raw hits, 0 excluded, 298 confirmed
China23 certificates (Class III 15 / II 8 / I 0), as of 2026-09-04
United Kingdom19 confirmed, 0 excluded
Brazil5 confirmed, 0 excluded
Manufacturer names merged into this page: HANGZHOU SINGCLEAN MEDICAL PRODUCTS CO LTD · HANGZHOU SINGCLEAN MEDICAL PRODUCTS CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000014098
EU authorised representative
Hangzhou Singclean Medical Products Filial Sweden
UK responsible person
SUNGO Certification Company Limited
Unified social credit code
91330101747181911R
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Hangzhou Zhejiang
Social-insurance enrolees
629
Annual revenue
over RMB 500M
Website
www.singclean.net
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentSurgical systems & instruments

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
2003-03-25
Registered capital
CNY 80,000,000
Paid-in capital
CNY 80,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Pharmaceutical manufacturing
Last approval date
2024-06-04
Recognitions
National High-Tech EnterpriseSRDI 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.

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20263400640人类免疫缺陷病毒(HIV1/2)尿液抗体检测试剂盒(胶体金法)Class III
CN国械注准20263130004注射用透明质酸钠溶液Class III
CN国械注准20253141622胶原贴敷料Class III
CN国械注准20233140614可吸收胶原蛋白止血海绵Class III
EU06936020160346Pretthyal®Class III
EU06936020160339Pretthyal®Class III
EU06936020160322Pretthyal®Class III
EU06936020106825Pretthyal®Class III
UK59131Cross-linked Sodium Hyaluronate Gel for Plastic SurgeryClass III
UK47887Modified Sodium Hyaluronate Gel for InjectionClass III
UK65841Follicle Stimulating Hormone (FSH) Test Kit (Colloidal Gold)IVD Devices for Self-Testing
BR80451960262Teste Rápido Nutriex - Microalbuminúria (MAU)Class II
BR80709159016Aplicador de partículas hemostáticas absorvíveis MPH Surgiclean®Class II
BR80451960245Nutriex GravidezClass II

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