HomeChinaJINAN BABIO BIOTECHNOLOGY CO.,LTD.

JINAN BABIO BIOTECHNOLOGY CO.,LTD.

China · 济南 · www.jnbaibo.com
✓ Record-verifiedregistrations found in 3 marketsEU SRN CN-MF-000012865Unified social credit code 913701007563575874

This company holds 78 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
78China registrations
Class I 48Class II 28
as of 2026-09-04
EUEuropean UnionEUDAMED
15UDI-DI device records
Class I 15
USUnited StatesFDA openFDA
25listed device types
Class I 23Class II 2Class III 0
plus 25 registration records and 1 510(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 Union15 raw hits, 0 excluded, 15 confirmed
United States25 registration records, 1 510(k), 0 PMA
China78 certificates (Class III 0 / II 28 / I 48), as of 2026-09-04
Manufacturer names merged into this page: JINAN BABIO BIOTECHNOLOGY CO.,LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000012865
EU authorised representative
MedPath GmbH
Unified social credit code
913701007563575874
Exhibition record
CMEF 89th (Apr 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
74
Annual revenue
RMB 10–30M
Website
www.jnbaibo.com
Product categories
体外诊断

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
2003-11-05
Registered capital
CNY 60,580,622
Paid-in capital
CNY 60,580,000
Legal form
Joint-stock limited company (unlisted, natural-person invested or controlled)
Industry classification
Wholesale trade
Last approval date
2026-02-06
Recognitions
National High-Tech EnterpriseTechnology-based SMEAbove-designated-size industrial enterprise
Listing
Listed on the NEEQ

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 510(k) clearances by year

12025 · K250205

FDA listed device types

showing 8 of 25
Container, Specimen Mailer And Storage, Sterile 1Iodine, Grams 1Culture Media, Enriched 1Culture Media, Non-Selective And Non-Differential 1Block, Heating 1Stain, Reticulocyte 1Hematoxylin 1Culture Media, Non-Propagating Transport 1

Registration details (sample)

MarketIdentifierNameClass / date
CN鲁械注准20262400112转铁蛋白检测试剂盒(胶体金法)Class II
CN鲁械注准20262400109尿微量白蛋白检测试剂盒(胶体金法)Class II
CN鲁械注准20262400108便隐血检测试剂盒(胶体金法)Class II
CN鲁械注准20262220179生殖道分泌物分析仪Class II
EU06975025179168SwabClass I
EU06975025179175SwabClass I
EU06975025179182SwabClass I
EU06975025177652Disposable Sampling SwabClass I
USK250205Babio® Virus Transport Kit (Non-inactivating)2025-09-22

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