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EUDAMED last updated this device on Apr 21, 2026
697524731002KGBreathalyzer is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Justec Shenzhen Co., Ltd.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0697524731003530501051 packaging level registered — each level carries its own UDI-DI.
06975247310035× 1 unitBase unit16975247310032× 1 unit(01)06975247310035
European Medical Device Nomenclature — the EU product classification assigned to this device.
V0399MEASUREMENT DEVICES - OTHER2 warnings recorded — scroll inside the panel to see all entries.
Disposable Mouthpiece are not designed to be reused. Reuse may cause a risk of contamination. Dry the device immediately in case of rain or water spray. Store and use the device in specified environmental condition. The device may not meet the performance specification due to aging, stored or used outside the specified temperature and humidity range. Contact the JUSTEC authorized service personnel for replacements if you find the equipment is damaged. NOTE: During normal use, the operator is expected to face the front of the equipment. Keep this manual in the vicinity of the equipment so that it can be conveniently referenced when needed. At the end of its service life, the equipment, as well as its accessories, must be disposed of in compliance with the local guidelines regulating the disposal of such products.
OTHER
Primary placement in Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Apr 21, 2026 | Nov 11, 2030 |
CN-MF-000036487The 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.
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 →This device is not currently linked to any other device.
No certificate specifically references this device's Basic UDI-DI.
No 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.