HomeUSANanofiber Solutions, Inc.

Nanofiber Solutions, Inc.

USA · Dublin
✓ 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
3listed device types
Class I 0Class II 2Class III 0unclassified 1
plus 6 registration records and 6 510(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 States6 registration records, 6 510(k), 0 PMA
Manufacturer names merged into this page: NANOFIBER SOLUTIONS LLC

Company information

Country
USA
City
Dublin

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

12018 · K173544
12019 · K183236
12020 · K201414
12023 · K231641
12024 · K241912
12025 · K250021

FDA listed device types

Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon 1Fastener, Fixation, Biodegradable, Soft Tissue 1Absorbable Synthetic Wound Dressing 1

Registration details (sample)

MarketIdentifierNameClass / date
USK250021Rotium2025-02-27
USK241912BIOCHARGE2024-07-29
USK231641Rotium Bioresorbable Wick2023-07-05

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