HomeChinaINTEGRAL MEDICAL PRODUCTS CO., LTD.

INTEGRAL MEDICAL PRODUCTS CO., LTD.

China · Shaoxing
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Taiwan, South Korea, Australia, Russia — 6 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 3Class II 5Class III 0
plus 12 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
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
8active device licences
Class II 8
11 including historic records
TWTaiwanTFDA
2valid device licences
Class II 2
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
4GMP quality-system certificates
Import 4
AUAustraliaTGA ARTG
12active ARTG entries
Class I 4IIa 5IIb 1Class Is (sterile) 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
2active registrations
Class 2a 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, 0 510(k), 0 PMA, 5 excluded
Brazil0 confirmed, 1 excluded
Canada8 confirmed, 0 excluded
Manufacturer names merged into this page: INTEGRAL MEDICAL PRODUCTS CO., LTD.

Company information

Country
China
City
Shaoxing

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 listed device types

Catheter, Malecot 1Catheter, Straight 1Catheter, Urological 1Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) 1Catheter, Urethral 1Mask, Gas, Anesthetic 1Airway, Oropharyngeal, Anesthesiology 1System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile 1

Registration details (sample)

MarketIdentifierNameClass / date
CA81410ENDOTRACHEAL TUBEClass II
CA81411LARYNGEAL MASK AIRWAYClass II
CA81412STOMACH TUBEClass II

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