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Sun Scientific, Inc.

USA · Dobbs Ferry

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Taiwan — 2 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

12listed device types

Class I 11Class II 1Class III 0

plus 15 registration records and 3 510(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

0active device licences

TWTaiwanTFDA

1valid device licences

Class II 1

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 States15 registration records, 3 510(k), 0 PMA, 100 excluded

Brazil0 confirmed, 10 excluded

Saudi Arabia0 confirmed, 5 excluded

Canada0 confirmed, 4 excluded

Manufacturer names merged into this page: SUN-SCIENTIFIC INC.

FDA 510(k) clearances by year

12007 · K070457

12019 · K183349

12023 · K222823

FDA listed device types

showing 8 of 12

Protector, Skin Pressure 1Accessories, Cleaning Brushes, For Endoscope 1Accessory, Surgical Apparel 1Splint, Extremity, Inflatable, External 1Non-Surgical Gown 1Dressing, Compression 1Fiber, Medical, Absorbent 1Dressing, Wound, Hydrophilic 1

Market	Identifier	Name	Class / date
US	K222823	AeroDVx Arm System	2023-09-07
US	K183349	AeroDVx System	2019-07-19
US	K070457	SUN SCIENTIFIC LLC-LEG COMPRESSOR AND PFAB	2007-05-16

Sun Scientific, Inc.

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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