Home›China›SteriLance Medical (Suzhou) Inc.

SteriLance Medical (Suzhou) Inc.

✓ Record-verifiedregistrations found in 13 marketsEU SRN CN-MF-000002860Unified social credit code 91320500753906536T

This company holds 26 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 12 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

26China registrations

Class I 12Class II 13Class III 1

as of 2026-09-04

EUEuropean UnionEUDAMED

≥300UDI-DI device records

Class I 53Class IIa 247

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

8listed device types

Class I 4Class II 4Class III 0

plus 17 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

19registered device records

Class I 7Class IIa 12

BRBrazilANVISA

95registered devices

Class I 19Class II 76

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

3active device licences

Class II 3

13 including historic records

TWTaiwanTFDA

46valid device licences

Class I 46

SGSingaporeHSA SMDR

7device registrations

CLASS B 7

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 3

AUAustraliaTGA ARTG

11active ARTG entries

Class I 2IIa 9

HKHong KongMDACS

4valid listings

Class II 4

ILIsraelAMAR

7registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 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 Union1,119 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States17 registration records, 10 510(k), 0 PMA

China26 certificates (Class III 1 / II 13 / I 12), as of 2026-09-04

United Kingdom19 confirmed, 0 excluded

Brazil95 confirmed, 0 excluded

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: Sterilance Medical (Suzhou) Inc. · STERILANCE MEDICAL (SUZHOU) INC. · SteriLance Medical (SuZhou) Inc. · STERILANCE MEDICAL (SUZHOU)

Regulatory identity

EU manufacturer SRN: CN-MF-000002860
EU authorised representative: Emergo Europe B.V.
UK responsible person: Obelis UK Ltd
Unified social credit code: 91320500753906536T
Exhibition record: CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Business registration

Registration status: Active
Incorporated: 2003-10-29
Registered capital: USD 5,100,000
Paid-in capital: USD 5,100,000
Legal form: Limited liability company (HK/Macao/Taiwan invested, not wholly owned, not wholly owned)
Industry classification: Pharmaceutical manufacturing
Last approval date: 2026-07-01
Recognitions: Micro and small enterpriseNational High-Tech EnterprisePrivate technology enterpriseSRDI SMERecognised enterprise technology centre

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

12016

12021

32022 · K221521

12024 · K233796

22025 · K244031

22026 · K260122

FDA listed device types

Multiple Use Blood Lancet For Single Patient Use Only 1Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature 1Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature 1Needle, Hypodermic, Single Lumen 1Handle, Scalpel 1Scalpel, One-Piece 1Blade, Scalpel 1Pack, Hot Or Cold, Reusable 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20153141779	胰岛素注射笔针头	Class III
CN	苏械注准20262220027	一次性使用末梢血样采集包	Class II
CN	苏械注准20252220548	一次性使用末梢采血器	Class II
CN	苏械注准20212220118	一次性使用末梢采血器	Class II
EU	16945630145114	STERiLANCE	Class IIa
EU	16945630145091	STERiLANCE	Class IIa
EU	16945630145084	STERiLANCE	Class IIa
EU	16945630145053	index	Class IIa
UK	58077	Alcohol Swabs	Class I
UK	44127	Disposable Insulin Pen Needles	Class IIa
UK	61579	Disposable Skin Prick Lancets	Class IIa
US	K260122	Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)	2026-07-06
US	K261634	Disposable Blood Lancet (Soft)	2026-06-12
US	K244031	Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense)	2025-02-26
BR	81840549035	LANCETA NEONATAL	Class II
BR	10098710048	LANCETADOR UNIQMED	Class I
BR	10369460222	LÂMINAS PARA BISTURI SOLIDOR	Class II
CA	91284	PEN NEEDLES	Class II
CA	93780	BLADE CARTRIDGES	Class II
CA	108542	MINICOLLECT PIXIE HEEL INCISION SAFETY LANCET	Class II