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EvoTears
EUDAMEDClass IIb (EU MDR)
Ref 55.1715Model Lubricating eye dropsRef 55.1692Ref 56.0068Ref 55.1823
Identity
- Trade Name
- EvoTears EUDAMED
- Device Name
- Perfluorohexyloctane ophthalmic solution EUDAMED
- Model / Reference
- Lubricating eye drops EUDAMED55.1715 EUDAMED55.1692 EUDAMED56.0068 EUDAMED55.1823 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04031626001443 EUDAMED04031626001498 EUDAMED04031626001535 EUDAMED04031626001436 EUDAMED
- Basic UDI-DI
- 4031626551134RA EUDAMED
- EMDN Code
- Q02030206 EYE LUBRICANT SOLUTIONS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Romania EUDAMEDIreland EUDAMEDCzechia EUDAMEDMalta EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
EvoTears by URSAPHARM Arzneimittel GmbH — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4031626551134RA | Class IIb | Active |
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Manufacturer
- Manufacturer
- URSAPHARM Arzneimittel GmbH
- EUDAMED SRN
- DE-MF-000007748
Sources (4)
- EUDAMED 29770de4-7583-4b81-bc2a-33cb58737a1b 61 fields · synced Jul 22, 2026
- EUDAMED e50baff2-6ade-400d-901c-2420268445d9 61 fields · synced May 17, 2026
- EUDAMED 4b00ba58-6512-4dce-9701-0c94e662a1f8 61 fields · synced May 17, 2026
- EUDAMED 8869ef21-b500-423c-a60c-94c6679fe20e 61 fields · synced May 18, 2026