- Organization name
- UDI-DI code
- Reference / catalog number
US-MF-000020408Lighted Ear Curette is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Bionix LLC. Placed on the EU market in Belgium. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Aug 24, 2026
859911004LightedCuretteKHPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)00714646001306
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Belgium; available across 18 countries total.
| Country | On market since | Until |
|---|---|---|
| BelgiumPrimary placement | Jun 3, 2026 | Jan 3, 2028 |
| Austria | Jun 3, 2026 | Jan 3, 2028 |
| Czechia | Jun 3, 2026 | Jan 3, 2028 |
| Germany | Jun 3, 2026 | Jan 3, 2028 |
| Denmark | Jun 3, 2026 | Jan 3, 2028 |
| EL | Jun 3, 2026 | Jan 3, 2028 |
| Spain | Jun 3, 2026 | Jan 3, 2028 |
| Finland | Jun 3, 2026 | Jan 3, 2028 |
| France | Jun 3, 2026 | Jan 3, 2028 |
| Hungary | Jun 3, 2026 | Jan 3, 2028 |
| Ireland | Jun 3, 2026 | Jan 3, 2028 |
| Iceland | Jun 3, 2026 | Jan 3, 2028 |
| Italy | Jun 3, 2026 | Jan 3, 2028 |
| Netherlands | Jun 3, 2026 | Jan 3, 2028 |
| Norway | Jun 3, 2026 | Jan 3, 2028 |
| Poland | Jun 3, 2026 | Jan 3, 2028 |
| Portugal | Jun 3, 2026 | Jan 3, 2028 |
| Sweden | Jun 3, 2026 | Jan 3, 2028 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
00714646001306Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
859911004LightedCuretteKH3410UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Q0399ENT DEVICES - OTHERNo certificate specifically references this device's Basic UDI-DI.
859911004SpeculumYHOn the marketLight Source859911004LightSourceNVOn the marketLighted Ear Curette859911004LightedCuretteKHOn the marketLighted Ear Curette859911004LightedCuretteKHOn the marketLighted Ear Curette859911004LightedCuretteKHOn the marketLighted Ear Curette859911004LightedCuretteKHOn the marketNo certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.