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Home›Korea, Republic›Prime Medical Inc.

Prime Medical Inc.

Korea, Republic · Hwaseong-Si Gyeonggi-do · www.primemedical-inc.com
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, United Kingdom, Saudi Arabia — 3 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
0UDI-DI device records
USUnited StatesFDA openFDA
9listed device types
Class I 9Class II 0Class III 0
plus 9 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
1registered device records
Class I 1
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
53registered 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
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.

European Union3,111 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified
United States9 registration records, 0 510(k), 0 PMA, 19 excluded
United Kingdom1 confirmed, 12 excluded
Brazil0 confirmed, 7 excluded
Saudi Arabia53 confirmed, 2 excluded
Canada0 confirmed, 2 excluded
Manufacturer names merged into this page: PRIME MEDICAL LLC · PRIME MEDICAL, INC. · Prime Medical LLC · Prime Medical Inc.
Same-named companies — This database also contains companies with near-identical names: PRIME MEDICAL INC, Prime Medical Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Regulatory identity

UK responsible person
QNET Ltd

Company information

Country
Korea, Republic
City
Hwaseong-Si Gyeonggi-do
Website
www.primemedical-inc.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesOrthopaedics, Trauma & RehabilitationExoskeletonsIntegrated Care, Rehabilitation & HomecareConsumables, disposables & infection control

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

showing 8 of 9
Bandage, Cast 1Instrument, Cast Removal, Ac-Powered 1Support, Patient Position 1Surgical Table Cushion 1Sling, Arm 1Tape, Orthopedic 1Tape And Bandage, Adhesive 1Bandage, Elastic 1

Registration details (sample)

MarketIdentifierNameClass / date
UK65178Head CradleClass I
SAME0000000923SFDAA00026Trendelenburg Anti-skid O.R. Table pad w/table rail straps, lift sheet—
SAME0000022001SFDAA00003Heel Protector Pair—

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