HomeChinaShenzhen Pango Medical Electronics Co., Ltd.

Shenzhen Pango Medical Electronics Co., Ltd.

China · Shenzhen · www.pangaohealth.com
✓ Record-verifiedregistrations found in 9 marketsEU SRN CN-MF-000023018

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, South Korea, Australia, Russia — 9 overseas markets. 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
8UDI-DI device records
Class IIa 8
USUnited StatesFDA openFDA
6listed device types
Class I 3Class II 3Class III 0
plus 13 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
4registered device records
Class IIa 4
BRBrazilANVISA
1registered devices
Class II 1
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
3 including historic records
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
5GMP quality-system certificates
Business type not stated 1Import 4
AUAustraliaTGA ARTG
1active ARTG entries
IIa 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
2active registrations
Class 2a 1Class 2b 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 Union8 raw hits, 0 excluded, 8 confirmed
United States13 registration records, 3 510(k), 0 PMA, 1 excluded
United Kingdom4 confirmed, 0 excluded
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: Shenzhen Pango Medical Electronics Co., Ltd · SHENZHEN PANGO MEDICAL ELECTRONICS CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000023018
EU authorised representative
Lotus NL B.V.
UK responsible person
lotus global co ltd

Company information

Country
China
City
Shenzhen
Website
www.pangaohealth.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 510(k) clearances by year

12022 · K212346
12023 · K223291
12024 · K240729

FDA listed device types

Sleeve, Limb, Compressible 1Continuous Measurement Thermometer 1System, Measurement, Blood-Pressure, Non-Invasive 1Orthosis, Lumbar 1Massager, Therapeutic, Electric 1Hearing Aid, Air-Conduction, Prescription 1

Registration details (sample)

MarketIdentifierNameClass / date
EU06948423815235Termometr bezdotykowyClass IIa
EU06948423815136Infrared Forehead ThermometerClass IIa
EU06948423806820Automatyczny cisnieniomierz stacjonarnyClass IIa
EU06948423808824Infrared Forehead ThermometerClass IIa
UK45617Electronic Blood Pressure MonitorsClass IIa
UK63711Infrared Ear / Forehead ThermometersClass IIa
UK10969Intermittent pneumatic compression unitsClass IIa
USK240729Electronic Blood Pressure Monitor (Model: PG-800B30, PG-800B38, PG-800B39, PG-800B45, PG-800B46, PG-800B47, PG-800B48, PG-800B53, PG-800B55, PG-800B56, PG-800B57, PG-800B58, PG-800B61)2024-06-14
USK223291Electronic Blood Pressure Monitor2023-06-14
USK212346Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT16182022-05-05
BR82791129001MONITOR DE PRESSAO ARTERIAL ARM SANUSClass II

Similar companies

Chengdu Cryo-Push Medical Technology Co. Ltd.
China · markets 8
Dalian Labtek Science and Development Co., Ltd
China · markets 7
FOSHAN HONGFENG CO., LTD
China · markets 9
Guangzhou Kapha Electronic Technology Co., Ltd
China · markets 0
Guangzhou Longest Science & Technology Co., Lt
China · markets 12
hengshui jingkang medical device co.,ltd
China · markets 2
Is this your company? Claim the page, add information or report a data error.Claim / report an error →