HomeChinaZhuhai DL Biotech Co., Ltd.

Zhuhai DL Biotech Co., Ltd.

China · Zhuhai Guangdong · en.medicaldl.com/?lang=en
✓ Record-verifiedregistrations found in 3 marketsUnified social credit code 914404007462893143

This company holds 85 NMPA certificates in China and has registrations in Brazil, Russia — 2 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
85China registrations
Class I 38Class II 47
as of 2026-09-04
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
40registered devices
Class I 13Class II 27
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
4active registrations
Class 2a 4
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 Union27,717 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified
United States0 registration records, 0 510(k), 0 PMA, 3 excluded
China85 certificates (Class III 0 / II 47 / I 38), as of 2026-09-04
United Kingdom0 confirmed, 52 excluded
Brazil40 confirmed, 1 excluded
Manufacturer names merged into this page: ZHUHAI DL BIOTECH CO., LTD. · ZHUHAI DL BIOTECH CO., LTD

Regulatory identity

Unified social credit code
914404007462893143
Exhibition record
CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Zhuhai Guangdong
Social-insurance enrolees
311
Annual revenue
RMB 100–500M
Website
en.medicaldl.com/?lang=en
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsMicrobiology & infectious disease diagnostics

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
2003-01-08
Registered capital
CNY 26,168,555
Paid-in capital
CNY 24,371,200
Legal form
Joint-stock limited company
Industry classification
Pharmaceutical manufacturing
Last approval date
2026-07-30
Recognitions
National High-Tech EnterpriseTechnology-based SMESRDI SMERecognised enterprise technology centreInnovative SMEAbove-designated-size industrial enterprise
Listing
Delisted from the NEEQ

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.

Registration details (sample)

MarketIdentifierNameClass / date
CN粤械注准20262400218MH琼脂培养基Class II
CN粤械注准20252401368厌氧菌鉴定药敏试剂盒(比色/比浊法)Class II
CN粤械注准20252400059链球菌药敏试剂卡Class II
CN粤械注准20242400761革兰阳性细菌药敏试剂盒(微量稀释法)Class II
BR80102512967Família Sistema Automático de Cultura de Sangue – Série BTClass II
BR80002670131Sistema identificação Microbiana - Espectrometria de massas (MALDI-TOFClass II
BR80002670133MATRIZ PARA USO COM MALDI-TOF MS - RENY DLClass I

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