HomeChinaHebei Dansong medical equipment Co., LTD

Hebei Dansong medical equipment Co., LTD

China · 太原
✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000047302Unified social credit code 91131121MA09J1UP79

This company holds 13 NMPA certificates in China and has registrations in European Union, United States, United Kingdom — 3 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
13China registrations
Class I 13
as of 2026-09-04
EUEuropean UnionEUDAMED
≥300UDI-DI device records
Class I 300
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
1listed device types
Class I 0Class II 1Class III 0
plus 1 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
2registered device records
Class I 2
BRBrazilANVISA
0registered devices
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
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.

European Union387 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified
United States1 registration records, 1 510(k), 0 PMA
China13 certificates (Class III 0 / II 0 / I 13), as of 2026-09-04
United Kingdom2 confirmed, 0 excluded
Manufacturer names merged into this page: HEBEI DANSONG MEDICAL TECHNOLOGY CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000047302
EU authorised representative
SUNGO Europe B.V.
UK responsible person
SUNGO Certification Company Limited
Unified social credit code
91131121MA09J1UP79
Exhibition record
Rehab & Elderly Care Expo (Spring 2026, Shanghai) · Rehab & Elderly Care Expo (Spring 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
6

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
2017-12-15
Registered capital
CNY 5,200,000
Paid-in capital
CNY 473,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2026-07-07
Recognitions
Micro and small 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

12025 · K252671

FDA listed device types

Wheelchair, Powered 1

Registration details (sample)

MarketIdentifierNameClass / date
CN冀衡械备20260247框式助行器Class I
CN冀衡械备20260091手动轮椅车Class I
CN冀衡械备20250119骨科牵引床Class I
CN冀衡械备20240346手动推车Class I
EU06978356680709Class I
EU06978356680501Class I
EU06978356680082Class I
EU06978356680075Class I
UK41875Electric WheelchairClass I
UK41512Manual WheelchairClass I
USK252671Electric wheelchair (NSDS-01)2025-11-03

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