← Back to catalogue
Faros surgical platform, anterior
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref VC840100Model MD1105.03 Faros Ophthalmic Surgery System510(k) K233398
Identity
- Trade Name
- Faros surgical platform, anterior EUDAMEDFaros EUDAMED
- Model / Reference
- MD1105.03 Faros Ophthalmic Surgery System EUDAMEDVC840100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630003909104 EUDAMED
- Basic UDI-DI
- 76300039MD110503TF EUDAMED
- Direct Marketing DI
- 07630003909104 EUDAMED
- EMDN Code
- Q020499,Q020699 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
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
Faros surgical platform, anterior by Oertli Instrumente Ag — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233398 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 76300039MD110503TF | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Oertli Instrumente AG
- EUDAMED SRN
- CH-MF-000016175
- Authorised Representative
- Oertli Ophthalmedic Österreich GmbH AT-AR-000003554
Sources (3)
- EUDAMED dcaa2d2c-b2d2-4a73-be0f-bf1d6d5a1ae8 85 fields · synced Jul 15, 2026
- EUDAMED 86af420a-a31f-44a9-a04f-fb5c342dc274 61 fields · synced Jul 15, 2026
- FDA 510(k) K233398 1 fields · synced May 18, 2026