HomeChinaHefei DentaFilm Medical Equipment Co., Ltd

Hefei DentaFilm Medical Equipment Co., Ltd

China · 合肥 · www.dentafilm.cn
✓ Record-verifiedregistrations found in 3 marketsUnified social credit code 91340111MA2TRAJD97

This company holds 10 NMPA certificates in China and has registrations in United States, Saudi Arabia — 2 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
10China registrations
Class I 2Class II 7Class III 1
as of 2026-09-04
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
1510(k) clearances
Class I 0Class II 0Class III 0
plus 0 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
1registered 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.

United States0 registration records, 1 510(k), 0 PMA
China10 certificates (Class III 1 / II 7 / I 2), as of 2026-09-04
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: Hefei DentaFilm Medical Equipment Co., Ltd

Regulatory identity

Unified social credit code
91340111MA2TRAJD97
Exhibition record
CMEF 89th (Apr 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
0
Annual revenue
RMB 100–500M
Website
www.dentafilm.cn
Product categories
口腔科器械医用成像器械

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
2019-05-30
Registered capital
CNY 109,665,173
Paid-in capital
CNY 98,750,813
Legal form
Limited liability company
Industry classification
Electrical machinery and equipment
Last approval date
2023-10-18
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseSRDI SMEInnovative SMEAbove-designated-size industrial enterprise

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

12022 · K214091

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20243061564口腔颌面锥形束计算机体层摄影设备Class III
CN皖械注准20242170094定制式固定义齿Class II
CN皖械注准20232170168定制式正畸矫治器Class II
CN皖械注准20232060215手术显微镜Class II
USK214091Dental Image Plate Scanner, Model DFC-4T-SMART2022-03-02
SAME0000002066SFDAA00002Surgical Microscopes

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