Accelerated Epi-Off Treatment (10Tx)
by Avedro, a Glaukos Company United States EUDAMED
Ref EP-004365 EMDN Q0299
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number085557400310003EH | Date1 Aug 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- KXL System Treatment Cards
- Model / Reference
- EP-004365
- Primary DI / UDI-DI
- 00855574003168
- Basic UDI-DI
- 085557400310003EH
- Direct Marketing DI
- 00855574003168
- EMDN Code
- Q0299 Ophthalmic devices - other
- Device Class
- Class I
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000038119
- Authorised representative
- Glaukos Netherlands B.V. NL-AR-000002685
Other devices from Avedro, a Glaukos Company
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED b5c42bcc-275b-4d5a-8c82-e3bd39388043