Home›China›SHANDONG HAPOOL MEDICAL TECHNOLOGY CO.,LTD

SHANDONG HAPOOL MEDICAL TECHNOLOGY CO.,LTD

China · Zibo City Shandong · www.hapool.cn

✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000037479

This company has registrations in European Union, United Kingdom, Australia, Israel — 4 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

3UDI-DI device records

Class IIa 3

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

8registered device records

Class IIa 8

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

1active ARTG entries

IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 Union3 raw hits, 0 excluded, 3 confirmed

United Kingdom8 confirmed, 0 excluded

Regulatory identity

EU manufacturer SRN: CN-MF-000037479
EU authorised representative: SUNGO Europe B.V.
UK responsible person: SUNGO Certification Company Limited

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06976574761293	PALEX	Class IIa
EU	06976574761293	PALEX	Class IIa
EU	06976574764027	PALEX	Class IIa
UK	58977	Infusion Sets	Class IIa
UK	58977	Intravenous Infusion Sets with Burette	Class IIa
UK	38569	Blood Transfusion Set	Class IIa

SHANDONG HAPOOL MEDICAL TECHNOLOGY CO.,LTD

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

Similar companies