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Shenzhen Homed Medical Device Co., Ltd.

✓ Record-verifiedregistrations found in 6 marketsEU SRN CN-MF-000016463

This company has registrations in European Union, United States, United Kingdom, Brazil, Israel, Russia — 6 overseas markets. EU UDI-DI records ≥120, 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

≥120UDI-DI device records

Class IIa 115Class IIb 5

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

USUnited StatesFDA openFDA

14listed device types

Class I 9Class II 5Class III 0

plus 33 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

5registered device records

Class IIa 4Class IIb 1

BRBrazilANVISA

6registered devices

Class I 1Class II 5

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

1registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 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 Union387 raw hits, 180 excluded, 120 confirmed. Large result set — only the first 300 verified

United States33 registration records, 4 510(k), 0 PMA

United Kingdom5 confirmed, 0 excluded

Brazil6 confirmed, 1 excluded

Manufacturer names merged into this page: SHENZHEN HOMED MEDICAL DEVICE CO LTD · SHENZHEN HOMED MEDICAL DEVICE CO.. LTD · SHENZHEN HOMED MEDICAL DEVICE CO., LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000016463
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
UK responsible person: SUNGO Certification Company Limited

FDA 510(k) clearances by year

12017 · K161586

12018 · K170886

12022 · K212395

12025 · K252616

FDA listed device types

showing 8 of 14

Unit, Filter, Membrane 1Mouthpiece, Breathing 1Set, Tubing And Support, Ventilator (W Harness) 1Cannula, Nasal, Oxygen 1Mask, Oxygen 1Nebulizer, Medicinal, Non-Ventilatory (Atomizer) 1Tubing, Pressure And Accessories 1Apparatus, Suction, Single Patient Use, Portable, Nonpowered 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06956937006650	JLN-2514AS(AHG-900)-American Health Gate	Class IIa
EU	06956937002942	JLN-2300Air EVOLU UNIVERSAL PISTON COMPRESOR nebulizer	Class IIa
EU	06956937005615	HM-HC04	Class IIa
EU	06956937005608	HM-HC03	Class IIa
UK	66295	Mesh Nebulizer	Class IIa
UK	35457	Piston Compressor Nebulizer	Class IIa
UK	63643	Portable Suction Unit	Class IIa
US	K252616	Portable oxygen concentrator (JLO-190P)	2025-12-22
US	K212395	Nebulizer	2022-03-25
US	K170886	HOMED Mesh Nebulizer	2018-06-21
BR	10343209039	INALADOR/NEBULIZADOR INCOTERM PORTÁTIL ULTRASSONICO MESH NB1100	Class II
BR	10343209040	Nebulizador Incoterm Compressor N100.I	Class II
BR	81596329019	AirPlus Inalador compressor - HC223	Class II

Shenzhen Homed Medical Device 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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