HomeChinaTAIAN DALU MEDICAL INSTRUMENTS CO., LTD

TAIAN DALU MEDICAL INSTRUMENTS CO., LTD

China · Taian Shandong · www.taiandalumed.com
✓ Record-verifiedregistrations found in 9 marketsEU SRN CN-MF-000003009Unified social credit code 9137090056405061XL

This company holds 17 NMPA certificates in China and has registrations in European Union, United States, Brazil, Saudi Arabia, Canada, Australia, Israel, Russia — 8 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
17China registrations
Class I 10Class II 7
as of 2026-09-04
EUEuropean UnionEUDAMED
82UDI-DI device records
Class I 16Class IIa 66
USUnited StatesFDA openFDA
2listed device types
Class I 1Class II 1Class III 0
plus 2 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
6registered devices
Class I 5Class II 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
6registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
1 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
3active ARTG entries
IIa 2Class Im (measuring) 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
3active registrations
Class 1 2Class 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 Union82 raw hits, 0 excluded, 82 confirmed
United States2 registration records, 1 510(k), 0 PMA
China17 certificates (Class III 0 / II 7 / I 10), as of 2026-09-04
United Kingdom0 confirmed, 1 excluded
Brazil6 confirmed, 0 excluded
Saudi Arabia6 confirmed, 0 excluded
Manufacturer names merged into this page: TAIAN DALU MEDICAL INSTRUMENT CO.,LTD. · TAIAN DALU MEDICAL INSTRUMENT CO., LTD. · Taian Dalu Medical Instrument Co., Ltd. · Taian Dalu Medical Instrument Co. Ltd · Taian Dalu Medical Instrument Co. Ltd. · Taian Dalu Medical Instrument Co Ltd

Regulatory identity

EU manufacturer SRN
CN-MF-000003009
EU authorised representative
Lotus NL B.V.
Unified social credit code
9137090056405061XL
Exhibition record
CMEF 89th (Apr 2024, Shanghai)

Company information

Country
China
City
Taian Shandong
Social-insurance enrolees
267
Annual revenue
RMB 50–100M
Website
www.taiandalumed.com
Product categories
Healthcare Infrastructure, Manufacturing & QualityDrug-Device & Radiopharmaceutical Technologies

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
2010-10-15
Registered capital
CNY 27,058,824
Paid-in capital
CNY 27,058,824
Legal form
Limited liability company
Industry classification
Pharmaceutical manufacturing
Last approval date
2026-04-24
Recognitions
National High-Tech EnterpriseGazelle enterpriseRecognised enterprise technology centre

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

12024 · K230423

FDA listed device types

Meter, Peak Flow, Spirometry 1Clip, Nose 1

Registration details (sample)

MarketIdentifierNameClass / date
CN鲁械注准20252080662气流雾化器Class II
CN鲁械注准20242140752生理性海水鼻腔喷雾器Class II
CN鲁械注准20232070644便携式肺功能仪Class II
CN鲁械注准20222140145一次性使用无菌药液转移器Class II
EU06970701965219mesilifeClass I
EU06970701961211UNIVERSAL MASK bebés& niñosClass I
EU06970701961228UNIVERSAL MASK adultosClass I
EU06970701962171UNIVERSAL MASK HARD TOUCH adultosClass I
USK230423Electronic Peak Flow Meter2024-02-23
BR10343200032ESPAÇADOR E100Class I
BR80275310096EspaçadorClass I
BR80275310090Medidor de Pico de Fluxo Expiratório G-TechClass I
SAME0000012066SFDAA00001Aerosol Chamber
SAME0000012067SFDAA00001Aerosol Chamber for Children

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