HomeChinaTianjin Rilifine Medical Device Co.,Ltd

Tianjin Rilifine Medical Device Co.,Ltd

China · 天津 · www.rilifine.com
✓ Record-verifiedregistrations found in 9 marketsEU SRN CN-MF-000026981Unified social credit code 91120113MA07967H28

This company holds 2 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, South Korea, Israel, Russia — 8 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
2China registrations
Class I 1Class II 1
as of 2026-09-04
EUEuropean UnionEUDAMED
3UDI-DI device records
Class I 1Class IIa 2
USUnited StatesFDA openFDA
3listed device types
Class I 0Class II 3Class III 0
plus 3 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
3registered device records
Class I 1Class IIa 2
BRBrazilANVISA
22registered devices
Class I 5Class II 17
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
5valid device licences
Class I 5
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 Union3 raw hits, 0 excluded, 3 confirmed
United States3 registration records, 2 510(k), 0 PMA
China2 certificates (Class III 0 / II 1 / I 1), as of 2026-09-04
United Kingdom3 confirmed, 0 excluded
Brazil22 confirmed, 0 excluded
Manufacturer names merged into this page: TIANJIN RILIFINE MEDICAL DEVICE CO.,LTD · TIANJIN RILIFINE MEDICAL DEVICE CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000026981
EU authorised representative
Sungo Cert GmbH
UK responsible person
Health Ignite Ltd.
Unified social credit code
91120113MA07967H28
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
10
Website
www.rilifine.com
Product categories
注输、护理和防护器械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
2021-03-03
Registered capital
CNY 6,000,000
Paid-in capital
CNY 5,550,000
Legal form
Limited liability company
Industry classification
Special-purpose equipment manufacturing
Last approval date
2024-01-11
Recognitions
Micro and small enterpriseNational 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.

FDA 510(k) clearances by year

22022 · K222246

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 1

Registration details (sample)

MarketIdentifierNameClass / date
CN津械注准20222220277一次性使用末梢采血针Class II
CN津械备20220439号采血笔Class I
EU16975522991062Class IIa
EU16975522992052Class IIa
EU16975522993004RILIFINEClass I
UK61579Ignite LancetsClass IIa
UK61579Disposable Sterile LancetClass IIa
UK37243Lancing DeviceClass I
USK222246Disposable Sterile Lancet2022-11-21
USK222055Disposable Sterile Lancet2022-11-15
BR80102519296Lancetas Descartáveis MedsignClass II
BR10160619023LANCETA DE SEGURANÇA INJEXClass II
BR82444379007Lanceta Estéril DescartávelClass II

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