Home›USA›Bionix

Bionix

✓ Record-verifiedregistrations found in 5 marketsEU SRN US-MF-000020408

This company has registrations in European Union, United States, United Kingdom, Australia, Israel — 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

67UDI-DI device records

Class I 67

USUnited StatesFDA openFDA

17listed device types

Class I 14Class II 3Class III 0

plus 17 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

11registered device records

Class I 11

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

2active ARTG entries

Class I 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

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.

European Union67 raw hits, 0 excluded, 67 confirmed

United States17 registration records, 2 510(k), 0 PMA, 2 excluded

United Kingdom11 confirmed, 1 excluded

Brazil0 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: BIONIX, LLC

Regulatory identity

EU manufacturer SRN: US-MF-000020408
EU authorised representative: Obelis s.a.
UK responsible person: Obelis UK Ltd

FDA 510(k) clearances by year

11985 · K852039

11986 · K860606

FDA listed device types

showing 8 of 17

Tube, Ear Suction 1Syringe, Irrigating (Non Dental) 1Light, Examination, Medical, Battery Powered 1Utensil, Eating 1Syringe, Ent 1Probe, Ent 1Massager, Therapeutic, Manual 1Applicator, Absorbent Tipped, Non-Sterile 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	00859911004290	OtoClear SprayWash	Class I
EU	00859911004672	Lighted Ear Curette	Class I
EU	00859911004573	Lighted Ear Curette	Class I
EU	00714646001313	Lighted Ear Curette	Class I
UK	62863	OtoClear® 60cc Syringe	Class I
UK	65187	OtoClear® Ear Irrigation Tips	Class I
UK	65445	Safe Ear Curettes	Class I
US	K860606	RADIACARE INTRAOPERATIVE RADIOTHERAPY SYSTEM	1986-03-20
US	K852039	FLEX-LOOP FLEXIBLE EAR CORETTE	1985-06-11

Bionix

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies