Organization name

Bionix LLC

SRN

US-MF-000020408

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• The person has previously had complications following ear irrigation procedures • There is a history of a middle ear infection in the last six weeks • There is discharge from the ear canal or ear pain or tenderness • The person has or suspects an ear drum perforation • The person has had ANY form of ear surgery • The person has cleft palate, repaired or not • The person has tympanostomy tubes • There is a foreign body present in the ear canal • There is a history of inner ear problems (especially vertigo)

  OTHER

Primary placement in Belgium; available across 18 countries total.

Trade name

OtoClear Syringe

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

00859911004948

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

859911004OtoClearNE

Reference / catalog number

7235

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

OtoClear 60cc Luer Lock Syringe Kit

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z12149099VARIOUS ENT INSTRUMENTS - OTHER

• Class I medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.