Identity
- Trade Name
- iTrack Advance EUDAMED
- Device Name
- Canaloplasty Microcatheter Kit with Advanced Delivery System EUDAMED
- Model / Reference
- iTrack-ADS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00893872001677 EUDAMED00893872001615 EUDAMED
- Basic UDI-DI
- 0893872001iTrack-ADSMR EUDAMEDB-00893872001615 EUDAMED
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
iTrack Advance by Nova Eye, Inc. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 0893872001iTrack-ADSMR | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0893872001iTrack-ADSMR | Class IIa | Active |
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Manufacturer
- Manufacturer
- Nova Eye, Inc.
- EUDAMED SRN
- US-MF-000011341
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (3)
- EUDAMED d6cea64b-0a10-4fa7-b65e-288f4b7120e3 61 fields · synced Jul 13, 2026
- EUDAMED cf1507ff-cfdc-4567-aaf9-32e1eb8c79fa 61 fields · synced May 16, 2026
- EUDAMED 18f2aaa4-896b-4945-9803-0f135867b8af 61 fields · synced Jul 9, 2026