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Shenzhen Lifotronic Technology Co., Ltd.

✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000005654

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Hong Kong, Israel, Russia — 8 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 2IVD A 20IVD B 59IVD C 47IVD general 172

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

5listed device types

Class I 1Class II 3Class III 0unclassified 1

plus 5 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

16registered device records

Class IIa 2Class IIb 2IVD A 7IVD general 5

BRBrazilANVISA

107registered devices

Class I 22Class II 85

109 including historic records

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

6valid listings

Class II 4Class III 2

ILIsraelAMAR

12registrations

RURussiaRoszdravnadzor

104active registrations

Class 1 12Class 2a 67Class 2b 12Class 3 13

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 Union1,130 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States5 registration records, 2 510(k), 0 PMA

United Kingdom16 confirmed, 0 excluded

Brazil107 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: Shenzhen Lifotronic Technology Co.,Ltd. · SHENZHEN LIFOTRONIC TECHNOLOGY CO., LTD. · Shenzhen Lifotronic Technology Co., Ltd.

Regulatory identity

EU manufacturer SRN: CN-MF-000005654
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
UK responsible person: Umedwings UK LTD

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06978139078082	VITROS™ ECL 86 Immunodiagnostic System	IVD A
EU	06978139078105	VITROS™ ECL 300 Immunodiagnostic System	IVD A
EU	06978139078099	VITROS™ ECL 260 Immunodiagnostic System	IVD A
EU	16975984060375	Sleeve	Class I
UK	38124	Airway Clearance System	Class IIa
UK	47652	Temperature Management System	Class IIb
UK	35968	Hb NEXT Hemoglobi n Analyzer (HPLC)	IVD A
US	K251076	Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)	2025-07-30
US	K192466	Air Compression Therapy System	2020-06-22
BR	80102512769	Anticorpo Antiperoxidase Tiroidiana (Imunoensaio de Eletroquimilumines	Class II
BR	80102512770	Kit de Triiodotironina Total (Imunoensaio de Eletroquimioluminescência	Class II
BR	80102512771	Kit de Tiroxina Livre (Imunoensaio de Eletroquimioluminescência)	Class II
SA	ME0000002565SFDAA00111	Lifotronic Warming Blanket	—

Shenzhen Lifotronic Technology Co., Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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