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Home›USA›NEO-MEDICAL CO., LTD.

NEO-MEDICAL CO., LTD.

USA · Sparks
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 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
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
90listed device types
Class I 64Class II 26Class III 0
plus 101 registration records and 8 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class I 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
3registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
1active device licences
Class III 1
8 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
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.

United States101 registration records, 8 510(k), 0 PMA, 24 excluded
Brazil1 confirmed, 3 excluded
Saudi Arabia3 confirmed, 0 excluded
Canada1 confirmed, 3 excluded
Manufacturer names merged into this page: SHANGHAI NEO-MEDICAL IMPORT & EXPORT CO., LTD. · NEO MEDICAL S.A. · NEO MEDICAL INC. · Neo Modulus (Shandong) Medical Sci-Tech Co., Ltd. · NEO MODULUS(SHANDONG)MEDICAL SCI-TECH CO., LTD. · NEO YUANDONG MEDICAL EQUIPMENTS LTD
Same-named companies — This database also contains companies with near-identical names: NEO MEDICAL S.A.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Sparks

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 510(k) clearances by year

12011
12017
22019
12021
12022
12024
12025

FDA listed device types

showing 8 of 90
Cap, Surgical 1Cushion, Flotation 1Device, Occlusion, Umbilical 1Bag, Urine Collecting, Ureterostomy 1Container, Specimen, Sterile 1Scissors, Medical, Disposable 1Pad, Eye 1Probe 1

Registration details (sample)

MarketIdentifierNameClass / date
USK250512Augmented Gingival Matrix2025-12-05
USK243693NEO Pedicle Screw System™2024-12-23
USK222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™2022-08-26
BR80114540017Esponja NasalClass I
SAME0000000077SFDAA00001Face mask disposable—
SAME0000000076SFDAA00002Vinyl disposable gloves—
CA84602V-CATH PICC CATHETER ONLYClass III

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