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Longeviti Neuro Solutions, LLC

USA · Baltimore

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Israel — 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

4listed device types

Class I 1Class II 3Class III 0

plus 8 registration records and 9 510(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

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States8 registration records, 9 510(k), 0 PMA

Manufacturer names merged into this page: Longeviti Neuro Solutions

FDA 510(k) clearances by year

12018

32020 · K203349

32021 · K212058

12023 · K231920

12026 · K260709

FDA listed device types

Filler, Bone Void, Non-Alterable Compound For Cranioplasty 1Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction 1Plate, Cranioplasty, Preformed, Non-Alterable 1Template 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260709	ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754)	2026-06-25
US	K231920	Longeviti ClearFit OTS Cranial Implant	2023-11-09
US	K212058	Longeviti ClearFit OTS Cranial Implants	2021-09-08

Longeviti Neuro Solutions, LLC

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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