- Role
- Country
- Date of registration
- Address
SK-MF-000003111UNItear® bez konzervačných látok očné roztokové kvapky is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Unimed Pharma spol. s r.o.. Placed on the EU market in Slovakia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Nov 25, 2025
8588009045UNItearsPFQ8Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)08588009046080
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
1 warning recorded — scroll inside the panel to see all entries.
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 Slovakia; available across 11 countries total.
| Country | On market since | Until |
|---|---|---|
| SlovakiaPrimary placement | — | Still on market |
| Austria | — | Still on market |
| Bulgaria | — | Still on market |
| Czechia | — | Still on market |
| Estonia | — | Still on market |
| Croatia | — | Still on market |
| Hungary | — | Still on market |
| Lithuania | — | Still on market |
| Latvia | — | Still on market |
| Romania | — | Still on market |
| Slovenia | — | 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.
08588009046080Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
8588009045UNItearsPFQ858UDI 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.
1 packaging level registered — each level carries its own UDI-DI.
08588009046080× 1 unitBase unit28588009046084× 300 unitsEuropean Medical Device Nomenclature — the EU product classification assigned to this device.
Q02030206EYE LUBRICANT SOLUTIONSNo certificate specifically references this device's Basic UDI-DI.
8588009045SeptoZINC4TOn the marketSeptoZINC® silmatilgad, lahus8588009045SeptoZINC4TOn the marketSeptoZINC® капки за очи, разтвор8588009045SeptoZINC4TOn the marketUNItears ® acu pilieni, šķīdums bez konservanta8588009045UNItearsPFQ8On the marketUNItears ® bez konzervačních látek oční kapky, roztok8588009045UNItearsPFQ8On the marketUNItears ® fără conservanți, picături oftalmice, soluție8588009045UNItearsPFQ8On 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.