HomeChinaGetein Biotech, Inc.

Getein Biotech, Inc.

China · 南京 · www.bio-gp.com.cn
✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000017986Unified social credit code 913201007360621166

This company holds 354 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Australia, Israel, Russia — 7 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
354China registrations
Class I 47Class II 249Class III 28
as of 2026-09-04
EUEuropean UnionEUDAMED
271UDI-DI device records
IVD A 3IVD B 85IVD C 35IVD general 148
USUnited StatesFDA openFDA
19listed device types
Class I 13Class II 6Class III 0
plus 19 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
583registered device records
IVD A 61IVD general 521IVD Devices for Self-Testing 1
BRBrazilANVISA
72registered devices
Class I 2Class II 70
80 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
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IVD Class 3 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
19active registrations
Class 2a 11Class 2b 7Class 3 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 Union271 raw hits, 0 excluded, 271 confirmed
United States19 registration records, 0 510(k), 0 PMA
China354 certificates (Class III 28 / II 249 / I 47), as of 2026-09-04
United Kingdom583 confirmed, 0 excluded
Brazil72 confirmed, 0 excluded
Manufacturer names merged into this page: GETEIN BIOTECH, INC. · GETEIN BIOTECH INC.

Regulatory identity

EU manufacturer SRN
CN-MF-000017986
EU authorised representative
CMC Medical Devices & Drugs SL
UK responsible person
CMC Medical Devices LTD
Unified social credit code
913201007360621166
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
999
Annual revenue
over RMB 500M
Website
www.bio-gp.com.cn
Product categories
体外诊断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
2002-03-08
Registered capital
CNY 507,153,517
Paid-in capital
CNY 507,153,517
Legal form
Joint-stock limited company (listed, natural-person invested or controlled)
Industry classification
Pharmaceutical manufacturing
Last approval date
2025-09-25
Recognitions
National High-Tech EnterpriseSRDI SMETechnology "Little Giant"Above-designated-size industrial enterprise
Listing
Listed on the A-share market

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 listed device types

showing 8 of 19
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine 1Radioimmunoassay, Total Triiodothyronine 1Radioimmunoassay, Thyroxine-Binding Globulin 1Radioimmunoassay, Total Thyroxine 1Real Time Nucleic Acid Amplification System 1Calibrator, Multi-Analyte Mixture 1Radioimmunoassay, Estriol 1Radioimmunoassay, Follicle-Stimulating Hormone 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20263401025传染病多项复合质控品Class III
CN国械注准20263401023病原体多项复合质控品Class III
CN国械注准20253402229肿瘤标志物复合质控品Class III
CN国械注准20253402184肺炎衣原体、肺炎支原体及腺病毒核酸联合检测试剂盒(荧光PCR法)Class III
EU06954414757651Calprotectin Fast Test Kit (Immunofluorescence Assay)IVD B
EU06954414757668Calprotectin Fast Test Kit (Immunofluorescence Assay)IVD B
EU06954414729405Calprotectin Fast Test Kit (Immunofluorescence Assay)IVD B
EU06954414729399Calprotectin Fast Test Kit (Immunofluorescence Assay)IVD B
UK457725'-NT CalibratorIVD general
UK457735'-NT ControlIVD general
UK531375'-NT Reagent Kit (POD Method)IVD general
BR81325990453Kit de Teste Rápido de fT4 (Ensaio de Imunofluorescência)Class II
BR81325990440MAGICL PRL (CLIA)Class II
BR81325990454MAGICL FT4 (CLIA)Class II

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