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CataRhex 3 easy surgical platform, anterior
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref VC821100CEModel MD1105.07 CataRhex 3 Ophthalmic Surgery System510(k) K133562
Identity
- Trade Name
- CataRhex 3 easy surgical platform, anterior EUDAMEDCataRhex 3 easy EUDAMED
- Model / Reference
- MD1105.07 CataRhex 3 Ophthalmic Surgery System EUDAMEDVC821100CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630003915723 EUDAMED
- Basic UDI-DI
- 76300039MD110507TP EUDAMED
- Direct Marketing DI
- 07630003915723 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
CataRhex 3 easy 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 | K133562 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 76300039MD110507TP | Class IIb | Active |
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Manufacturer
- Manufacturer
- Oertli Instrumente AG
- EUDAMED SRN
- CH-MF-000016175
- Authorised Representative
- Oertli Ophthalmedic Österreich GmbH AT-AR-000003554
Sources (3)
- EUDAMED 317040b5-d512-4350-8685-a9ad8418bb0c 85 fields · synced Jun 18, 2026
- EUDAMED e3cad39e-9c0f-46ea-b9bf-66cada2ee2b7 61 fields · synced Jun 18, 2026
- FDA 510(k) K133562 1 fields · synced May 18, 2026