HomeChinaShijiazhuang Aofeite Imp. & Exp. Co.,LTD

Shijiazhuang Aofeite Imp. & Exp. Co.,LTD

China · Shijiazhuang Hebei · www.aofitmed.com
✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000011825

This company has registrations in European Union, United States, United Kingdom, Saudi Arabia, Australia — 5 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
pendingnot queried
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
28listed device types
Class I 27Class II 0Class III 0unclassified 1
plus 29 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
7registered device records
Class I 7
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
29registered 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
1active ARTG entries
Class I 1
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 Union1,035 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified
United States29 registration records, 0 510(k), 0 PMA
United Kingdom7 confirmed, 0 excluded
Saudi Arabia29 confirmed, 0 excluded
Manufacturer names merged into this page: Shijiazhuang Aofeite Medical Device Co.,Ltd · Shijiazhuang Aofeite Medical Device co., Ltd. · shijiazhuang aofeite imp&exp co.ltd · Shijiazhuang AoFeiTe Im&Ex Co.,Ltd · Shijiazhuang Aofeite Medical Device co., Ltd

Regulatory identity

EU manufacturer SRN
CN-MF-000011825
EU authorised representative
SUNGO Europe B.V.
UK responsible person
SUNGO Certification Company Limited

Company information

Country
China
City
Shijiazhuang Hebei
Website
www.aofitmed.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesOrthopaedics, Trauma & RehabilitationPhysiotherapy equipment

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.

FDA listed device types

showing 8 of 28
Orthosis, Lumbar 1Mattress, Flotation Therapy, Non-Powered 1Splint, Hand, And Components 1Insoles, Medical 1Cane, Safety Walk 1Crutch 1Exerciser, Non-Measuring 1Orthosis, Limb Brace 1

Registration details (sample)

MarketIdentifierNameClass / date
EU06953751916103Class I
EU06953751916110Class I
EU06953751916134Class I
EU06953751916141Class I
UK36206 Ankle sleeveClass I
UK41039Air neck tractionClass I
UK41053Elbow braceClass I
SAME0000004902SFDAA00009Arina upper limb brace
SAME0000004902SFDAA00002Relieve Postural Support

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