- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Apr 22, 2026
80540851219P4Osmotears Ultra Low OS 180 (OS180-001) is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by ENABLE INNOVATIONS SRL. Placed on the EU market in Denmark. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08054085120636050204IT-MF-0000260660425-MDR-030119-01(01)08054085120636
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
3 warnings 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 Denmark; available across 3 countries total.
| Country | On market since | Until |
|---|---|---|
| DenmarkPrimary placement | Feb 3, 2025 | Feb 2, 2030 |
| Norway | Feb 3, 2025 | Feb 2, 2030 |
| Sweden | Feb 3, 2025 | Feb 2, 2030 |
European Medical Device Nomenclature — the EU product classification assigned to this device.
Q0299OPHTHALMIC DEVICES - OTHERPrimary 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 →80540851206NTOn the marketOptikomax (HAPlusP-006)80540851221NPOn the marketOsmotears Low OS 280 (OS280-001)80540851220NMOn the marketPerflo drops Gocce oculari (GOF1bM-011)80540851202NKOn the marketPerflo drops Gocce oculari (GOF1bM-011)80540851202NKOn the marketPnemoair Aerosol (S3-004)80540851210NJOn the marketCertificate health across this manufacturer's portfolio.
0425-MDR-030179-00Issued0425-MDR-030119-01Supplemented0425-MDR-030020-01Supplemented0425-MDR-030120-00IssuedNotified 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.
View in glossary →Notified 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.
View in glossary →Notified 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.
View in glossary →Notified 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.
View in glossary →