HomeUSAElliquence, LLC

Elliquence, LLC

USA · Baldwin
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 9 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
20listed device types
Class I 17Class II 3Class III 0
plus 30 registration records and 8 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
18registered devices
Class I 4Class II 14
35 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
9 including historic records
TWTaiwanTFDA
3valid device licences
Class I 1Class II 2
SGSingaporeHSA SMDR
3device registrations
CLASS B 2CLASS C 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
8active ARTG entries
Class I 1IIa 2IIb 5
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
2active registrations
Class 2a 1Class 2b 1
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 States30 registration records, 8 510(k), 0 PMA
Brazil18 confirmed, 0 excluded
Manufacturer names merged into this page: ELLIQUENCE LLC · ELLIQUENCE, LLC

Company information

Country
USA
City
Baldwin

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

12010
12013
12015
12016
22017
12018
12025

FDA listed device types

showing 8 of 20
Electrosurgical, Cutting & Coagulation & Accessories 1Arthroscope 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Motor, Surgical Instrument, Ac-Powered 1Instrument, Cutting, Orthopedic 1Rongeur 1Accessories, Cleaning Brushes, For Endoscope 1Cannula, Surgical, General & Plastic Surgery 1

Registration details (sample)

MarketIdentifierNameClass / date
USK243739AxCess® Expandable Interbody System2025-01-24
USK180766Endiscope, Endiscope Cervical2018-06-11
USK170107Surgi Max Ultra2017-05-03
BR10275169006AGULHA ELLIQUENCEClass II
BR10275169008GRASPING FORCEPS ELLIQUENCEClass I
BR81021300013Cânula Elliquence DFX-NClass II

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