Home›Italy›BIOS S.R.L.

BIOS S.R.L.

Italy · Vimodrone Milano

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Taiwan, South Korea, Israel, Russia — 5 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 0Class II 4Class III 0

plus 8 registration records and 14 510(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

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

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 States8 registration records, 14 510(k), 0 PMA, 2 excluded

Brazil0 confirmed, 3 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: BIOS S.R.L.

FDA 510(k) clearances by year

12005

12007

12008

12015

22016

22020

12021

32023

22024

FDA listed device types

Massager, Vacuum, Radio Frequency Induced Heat 1Electrosurgical, Cutting & Coagulation & Accessories 1Powered Laser Surgical Instrument 1Stimulator, Muscle, Powered, For Muscle Conditioning 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K243445	Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)	2024-12-30
US	K241407	Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)	2024-06-14
US	K230755	NuEra Tight RF Model OptiStream	2023-10-30

BIOS S.R.L.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies