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SHANDONG INTCO MEDICAL PRODUCTS CORPORATION LTD.

China · Zibo

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Australia, Israel, Russia — 8 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

pendingnot queried

USUnited StatesFDA openFDA

8listed device types

Class I 5Class II 3Class III 0

plus 12 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

45registered devices

Class I 45

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

21registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

1active device licences

Class II 1

21 including historic records

TWTaiwanTFDA

17valid device licences

Class I 17

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

38active ARTG entries

Class I 38

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

18registrations

RURussiaRoszdravnadzor

2active registrations

Class 1 2

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.

United States12 registration records, 5 510(k), 0 PMA, 16 excluded

Brazil45 confirmed, 14 excluded

Saudi Arabia21 confirmed, 17 excluded

Canada1 confirmed, 2 excluded

Manufacturer names merged into this page: SHANDONG INTCO MEDICAL PRODUCTS CO LTD · SHANDONG INTCO HYGIENE PRODUCTS CO., LTD. · SHANDONG INTCO MEDICAL PRODUCTS CORPORATION LTD. · SHANDONG INTCO MEDICAL PRODUCTS CO., LTD. · Shandong Intco Medical Products Co., Ltda · Shandong Intco Medical Products Co. Ltd

FDA 510(k) clearances by year

12022 · K213509

32023 · K233042

12025 · K241064

FDA listed device types

Tampon, Menstrual, Unscented 1Electrode, Electrocardiograph 1Mask, Surgical 1Pad, Menstrual, Unscented 1Vinyl Patient Examination Glove 1Polymer Patient Examination Glove 1Medical Glove, Specialty 1Latex Patient Examination Glove 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K241064	Unscented Tampon	2025-01-10
US	K233042	Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl Citrate	2023-12-06
US	K231408	Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile	2023-08-11
BR	82944390006	Luva Para Procedimento Não Cirúrgico Nitrílica Azul, Preta e Violeta	Class I
BR	82944390007	Luva Para Procedimento Não Cirúrgico Vinil Transparente	Class I
BR	80695710045	LUVA NITRÍLICA PARA PROCEDIMENTOS NÃO CIRÚRGICOS BIODESC	Class I
SA	ME0000010661SFDAA00001	Intco SynGuard Vinyl Examination Gloves Powder Free	—
SA	ME0000010661SFDAA00002	Intco Synguard Nitrile Powder Free Examination Gloves	—
CA	96395	KEEPKLEEN VINYL- DISPOSABLE GLOVE	Class II

SHANDONG INTCO MEDICAL PRODUCTS CORPORATION LTD.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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