HomeUSASunMed Group Holdings, LLC

SunMed Group Holdings, LLC

USA · Grand Rapids
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, 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
pendingnot queried
USUnited StatesFDA openFDA
131listed device types
Class I 65Class II 61Class III 2unclassified 3
plus 260 registration records and 7 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class I 1Class II 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
4registered 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.

United States260 registration records, 7 510(k), 0 PMA, 6 excluded
Brazil2 confirmed, 3 excluded
Saudi Arabia4 confirmed, 5 excluded
Canada0 confirmed, 3 excluded
Manufacturer names merged into this page: SunMed Group Holdings, LLC · SUNMED, LLC · SUNMED LLC

Company information

Country
USA
City
Grand Rapids

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

11993 · K921263
21996 · K955631
12007 · K062112
12008 · K081805
12013 · K121743
12024 · K233098

FDA listed device types

showing 8 of 131
Anesthesia Breathing Circuit Kit (Adult & Pediatric) 1Bag, Urine Collecting, Ureterostomy 1Orthosis, Lumbar 1Stethoscope Head 1Mouthpiece, Breathing 1Circuit, Breathing (W Connector, Adaptor, Y Piece) 1Airway Suction Kit 1Forceps 1

Registration details (sample)

MarketIdentifierNameClass / date
USK233098MYOTouch Muscle Stimulator2024-08-02
USK121743EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN2013-03-28
USK081805CUFFALERT2008-11-14
BR80766140001IGuard Eye Protector EstérilClass I
BR81027710001Bougie - Introdutor de Tubo TraquealClass II
SAME0000006850SFDAA00022Oropharyngeal Guedel Airway
SAME0000006850SFDAA00024Laryngoscope Handle

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