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EUDAMED last updated this device on Jun 4, 2026
80540851205NRTOP 1 PLUS EYE DROPS (GOXP-003) 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 France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
IT-MF-0000260660425-MDR-030119-01(01)08054085122319
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 France; available across 3 countries total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary placement | May 13, 2026 | Feb 2, 2030 |
| Germany | May 13, 2026 | Feb 2, 2030 |
| Italy | May 13, 2026 | Feb 2, 2030 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
08054085122319Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
80540851205NR050605UDI 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.
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 →80540851213NQOn the marketTearcross Plus (GOF1bM-013)80540851202NKOn the marketTG1 occhi MIRTIdrop (GOBBM-023)80540851204NPOn the marketTrilen plus (GOF1aP-007)80540851201NHOn the marketTrilen plus (GOF1aP-007)80540851201NHOn the marketTussodep (S3-010)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 →