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EUDAMED last updated this device on Jun 14, 2023
B-10704F4HEALITE II is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Lutronic Corporation. Placed on the EU market in Greece. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
D-10704F4HEALITE IID-10704F4
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12040299GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - OTHERKR-MF-0000090359744-2017-CE-KOR-NA-PSPrimary placement in EL; available across 11 countries total.
| Country | On market since | Until |
|---|---|---|
| ELPrimary placement | May 28, 2021 | Dec 31, 2029 |
| Belgium | Sep 16, 2021 | Dec 31, 2029 |
| Bulgaria | Feb 11, 2022 | Dec 31, 2029 |
| Cyprus | Jan 25, 2022 | Dec 31, 2029 |
| Czechia | Mar 24, 2023 | Dec 31, 2029 |
| Germany | Jul 21, 2021 | Dec 31, 2029 |
| France | Jul 2, 2021 | Dec 31, 2029 |
| Hungary | Sep 10, 2021 | Dec 31, 2029 |
| Italy | Oct 28, 2021 | Dec 31, 2029 |
| Poland | Dec 17, 2021 | Dec 31, 2029 |
| Romania | Aug 12, 2021 | Dec 31, 2029 |
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.
View in glossary →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.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →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.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →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.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Certificate health across this manufacturer's portfolio.
2975-MED-2601901IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
C555614CancelledNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
No certificate specifically references this device's Basic UDI-DI.