HomeChinaChangsha Renji Medical Equipment Co., Ltd.

Changsha Renji Medical Equipment Co., Ltd.

China · 长沙 · www.renjigroup.com
✓ Record-verifiedregistrations found in 3 marketsEU SRN CN-MF-000030318Unified social credit code 91430181MA4RPFWQ23

This company holds 17 NMPA certificates in China and has registrations in European Union, United States — 2 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
17China registrations
Class I 14Class II 3
as of 2026-09-04
EUEuropean UnionEUDAMED
1UDI-DI device records
IVD A 1
USUnited StatesFDA openFDA
15listed device types
Class I 14Class II 1Class III 0
plus 15 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
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 Union1 raw hits, 0 excluded, 1 confirmed
United States15 registration records, 0 510(k), 0 PMA
China17 certificates (Class III 0 / II 3 / I 14), as of 2026-09-04
Manufacturer names merged into this page: CHANGSHA RENJI MEDICAL EQUIPMENT CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000030318
EU authorised representative
Medunion S.L.
Unified social credit code
91430181MA4RPFWQ23
Exhibition record
CMEF 89th (Apr 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
50
Annual revenue
under RMB 5M
Website
www.renjigroup.com
Product categories
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
2020-09-25
Registered capital
CNY 40,000,000
Paid-in capital
CNY 9,000,000
Legal form
Limited liability company
Industry classification
Pharmaceutical manufacturing
Last approval date
2026-08-24
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SME

Business registration data from Tianyancha, as of 2026-09-03. 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 15
Transport Medium, Notified Per The Vtm Guidance 1Container, Specimen, Sterile 1Container, Specimen Mailer And Storage, Sterile 1Clinical Sample Concentrator 1Pipette, Pasteur 1Container, Specimen, Non-Sterile 1Micro Pipette 1Culture Media, Non-Propagating Transport 1

Registration details (sample)

MarketIdentifierNameClass / date
CN湘械注准20252220065一次性使用末梢血样采集容器Class II
CN湘械注准20232220565一次性使用人体静脉血样采集容器Class II
CN湘械注准20232181215一次性使用无菌阴道扩张器Class II
CN湘长械备20250144号沙门志贺(SS)琼脂培养基Class I
EU06975473970829Blood Collection TubeIVD A

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