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IT-MF-000029670MAIA is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by F.A.R.O. Fabbrica Apparecchiature Razionali Odontoiatriche Società per Azioni. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Jul 8, 2026
803402839MAIA9HPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)08034028394621
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
5 warnings recorded — scroll inside the panel to see all entries.
The physician is required to use disposable covers on the handles of the lamps or to disinfect or sterilize them after each patient. For surface disinfection, use appropriate disinfectants. The handles cannot be disinfected by thermodisinfection.
Do not use the lamp if its components are damaged. The supply voltage must always be disconnected during installation. Check the mainplate before installation. Check that the supply voltage indicated on the mainplate corresponds to the mains voltage. The dental lamp must be installed on a control and power supply device (e.g. dental units), or with an electrical system that complies with IEC 60364-1 and the "National rules for the installation of electrical systems in medical premises". The device must be installed with an omnipolar mains disconnecting device in accordance with IEC 61058-1, approved for a transient mains voltage of 4KV. Installation and maintenance of the device in accordance with IEC 60601-1 is the responsibility of the installer or the device manufacturer. Do not carry out any maintenance on the lamp when the power supply is on: disconnect the power cable from the mains before carrying out any work. Rotating the head and arms beyond the stops can damage the conductor insulation. Do not spra
do not stare into light beam The dental lamp is classified according to IEC 62471 as class 1 for blue retinal risk. Do not look at or direct the light beam directly into the patient's eyes, especially for patients with an increased risk of eye damage (e.g. children, elderly patients with eye diseases). In this case, always use appropriate protection and precautions. However, it cannot be excluded that patients who are particularly photosensitive or who have taken photosensitising medication may experience erythema or allergic reactions to light. In this case, discontinue the treatment and use very low levels of illumination
OTHER
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 Italy; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | Apr 9, 2012 | Still on market |
| Austria | — | Still on market |
| Belgium | — | Still on market |
| Bulgaria | — | Still on market |
| Cyprus | — | Still on market |
| Czechia | — | Still on market |
| Germany | — | Still on market |
| Denmark | — | Still on market |
| Estonia | — | Still on market |
| EL | — | Still on market |
| Spain | — | Still on market |
| Finland | — | Still on market |
| France | — | Still on market |
| Croatia | — | Still on market |
| Hungary | — | Still on market |
| Ireland | — | Still on market |
| Iceland | — | Still on market |
| Liechtenstein | — | Still on market |
| Lithuania | — | Still on market |
| Luxembourg | — | Still on market |
| Latvia | — | Still on market |
| Malta | — | Still on market |
| Netherlands | — | Still on market |
| Norway | — | Still on market |
| Poland | — | Still on market |
| Portugal | — | Still on market |
| Romania | — | Still on market |
| Sweden | — | Still on market |
| Slovenia | — | Still on market |
| Slovakia | — | Still on market |
| Türkiye | — | Still on market |
| XI | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
08034028394621Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
803402839MAIA9H322410300UDI 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.
Z12110180INSTRUMENTS FOR DENTAL TREATMENT UNITS - HARDWARE ACCESSORIESNo 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.No certificate specifically references this device's Basic UDI-DI.