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Civco Medical Solutions

USA · Kalona

✓ Record-verifiedregistrations found in 6 markets

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

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

10510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

13registered devices

Class I 13

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

SASaudi ArabiaSFDA

81registered imported devices

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

CACanadaMDALL

4active device licences

Class II 4

22 including historic records

TWTaiwanTFDA

2valid device licences

Class I 1Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class I 2

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 States0 registration records, 10 510(k), 0 PMA, 4 excluded

Brazil13 confirmed, 3 excluded

Saudi Arabia81 confirmed, 0 excluded

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: CIVCO MEDICAL INSTRUMENTS CO., INC. DBA CIVCO AND CIVCO MEDICAL SOLUTIONS · CIVCO MEDICAL SOLUTIONS SOFTWARE GROUP · MEDTEC,INC. DBA CIVCO MEDICAL SOLUTIONS AND CIVCO RADIOTHERAPY · CIVCO MEDICAL SOLUTIONS · MEDTEC, INC D/B/A CIVCO MEDICAL SOLUTIONS AND CIVCO RADIOTHERAPY · CIVCO Medical Instruments Co., Inc DBA CIVCO and CIVCO Medical Solutions

Registration details (sample)

Market	Identifier	Name	Class / date
US	K233109	TP Pivot Pro Needle Guide	2023-12-22
US	K211001	C-Qual M Breastboard; Monarch Overhead Arm Positioner	2021-05-20
US	K190802	Envision ultrasound pad and cover	2019-05-24
BR	80102512819	Almofada Vac-Lok	Class I
BR	80102512820	Sistema de Imobilização Solstice SRS	Class I
BR	80117580154	Almofada Vac-Lok	Class I
SA	ME0000006496SFDAA00050	Micro-Touch® Stabilizer LP	—
SA	ME0000006496SFDAA00050	Micro-Touch® Stabilizer LP	—
CA	21392	NEO-FLEX (POLYCHLOROPRENE) LATEX-FREE ULTRASOUND TRANSDUCER COVER	Class II
CA	72660	COLLECTEVAC	Class II
CA	100156	INTUIT TRANSDUCER COVER WITH PEELSAFE ADVANTAGE	Class II

Civco Medical Solutions

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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