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EUDAMED last updated this device on May 15, 2026
754016166AS88E4QLabex Canada is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Labex Canada Inc.. Placed on the EU market in Slovakia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
00628448120489LC-AS88-E(01)00628448120489
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0202059001IMMUNOHISTOCHEMISTRY PROCESSORS2 warnings recorded — scroll inside the panel to see all entries.
1) This product is for in vitro diagnosis use only. Read a familiarize yourself with the following warnings carefully before use and strictly follow them during the instrument operation. 2) The instrument must be connected only to a grounded outlet. 3) The instrument must be connected only to a power source compliant to the information on the instrument’s label. 4) Keep away from strong electromagnetic fields as interference can occur. 5) Keep away from humid and dusty environment, avoid exposure to direct, strong light; 6) Use of flammable, explosive, acidic or volatile gases in the proximity of the stainer shall be avoided. 7) Keep sufficient space around the power outlet in order to be able to unplug the power cord in emergencies. 8) Considering heat dissipation of this instrument, keep a space of at least 30 cm between the wall and the rear panel of the instrument. 9) Keep a space of at least 30 cm between the walls and both sides of the instrument. 10) The ground used for the instrument placement should be flat and solid, with the weight bearing capacity of at least 200 kg. Also, sufficiently large and stable desk with the weight bearing capacity of at least 200 kg should be provided for the instrument. 11) Protect the power cord from excessive forces (pulling, pushing, impacts) as it can be damaged causing short circuit or fire. 12) Avoid violent shaking and forceful impacts to the instrument.
1) Make sure that this instrument is powered only from grounded and stable power source. 2) Do not use the power supply different from the one mentioned on the label. Failure to do so can cause fire or electric shock. 3) Use only the three-core power cord supplied with this instrument. Keep the instrument properly grounded all the time. 4) Be aware of any damage of the power cord insulation sheath. Do not pull the power cord with excessive force. Failure to do so can cause a short circuit resulting in electric shock or fire. 5) Always turn off the power supply when connecting a peripheral device. Failure to do so may cause electric shock or device malfunction. 6) Avoid contact with any electronic circuit boards inside of the instrument. Electric shock may occur. 7) Keep all the compartments closed during the instrument’s operation. 8) In the event of abnormal odor, smoke or sound during the operation, immediately turn off the power supply by removing the power plug from the outlet. Immediately arrange for inspection by the distributor or manufacturer’s representative. Continued use of the damaged instrument may result in fire, electric shock, personal injury or death. 9) Prevent conductive materials (reagents, staples, others) inside the instrument. Failure to do so can damage the device, cause fire or create a short circuit. If any of this is detected, immediately turn off the power supply by removing the power plug from the outlet. Immediately arrange for instrument’s inspection by the distributor or manufacturer’s representative.
Primary placement in Slovakia; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| SlovakiaPrimary placement | — | Still on market |
CA-MF-000039965The 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 →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 →IVDR risk classes
IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.
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 →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.