HomeChinaNingbo David Medical Device Co.,Ltd

Ningbo David Medical Device Co.,Ltd

China · Ningbo · www.nbdavid.com
✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000009962Unified social credit code 91330200610257495J

This company holds 48 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Australia, Israel, Russia — 7 overseas markets. EU UDI-DI records ≥64, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
48China registrations
Class I 7Class II 24Class III 17
as of 2026-09-04
EUEuropean UnionEUDAMED
≥64UDI-DI device records
Class I 15Class IIa 8Class IIb 41
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
1510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
8registered device records
Class I 1Class IIa 2Class IIb 5
BRBrazilANVISA
2registered devices
Class II 2
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
2active ARTG entries
IIa 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
RURussiaRoszdravnadzor
5active registrations
Class 2a 2Class 2b 3
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 Union320 raw hits, 36 excluded, 64 confirmed. Large result set — only the first 300 verified
United States0 registration records, 1 510(k), 0 PMA, 16 excluded
China48 certificates (Class III 17 / II 24 / I 7), as of 2026-09-04
United Kingdom8 confirmed, 9 excluded
Brazil2 confirmed, 1 excluded
Saudi Arabia0 confirmed, 2 excluded
Manufacturer names merged into this page: NINGBO DAVID MEDICAL DEVICE CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000009962
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)
UK responsible person
Patient Guard Limited
Unified social credit code
91330200610257495J
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Ningbo
Social-insurance enrolees
633
Annual revenue
over RMB 500M
Website
www.nbdavid.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentAnaesthesia, intensive care & life-support systems

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
1992-09-18
Registered capital
CNY 288,000,000
Paid-in capital
CNY 288,000,000
Legal form
Joint-stock limited company (listed, natural-person invested or controlled)
Industry classification
Pharmaceutical manufacturing
Last approval date
2020-05-09
Recognitions
National High-Tech EnterpriseNational SRDI "Little Giant"SRDI SMEAbove-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 510(k) clearances by year

12019 · K190494

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20263081425呼吸机Class III
CN国械注准20263080625一氧化氮治疗仪Class III
CN国械注准20263080116婴儿转运培养箱Class III
CN国械注准20263071478多参数监护仪Class III
EU06920716320183Calentador RadianteClass IIb
EU06920716320244Calentador RadianteClass IIb
EU06920716320213Calentador RadianteClass IIb
EU06920716320060Incubadora InfantilClass IIb
UK36025Infant IncubatorClass IIb
UK36956Neonate Hypothermia DeviceClass IIb
UK11049Infant BedClass I
USK190494Infant Incubator2019-11-25
BR80231130010EQUIPAMENTO DE FOTOTERAPIA CTI XHZ - 90LClass II
BR10227189023BILIRRUBINOMETRO TRANSCUTANEOClass II

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