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CataRhex 3 surgical platform, anterior
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref VC821100Model MD1105.07 CataRhex 3 Ophthalmic Surgery System
Identity
- Trade Name
- CataRhex 3 surgical platform, anterior EUDAMEDCataRhex 3 EUDAMEDOertli® FDA UDI
- Generic Name
- Phacoemulsification system FDA UDI
- Device Name
- CATARHEX 3 PHAKO GERÄT; CATARHEX 3 PHACO UNIT; CATARHEX 3 APPAREIL PHACO FDA UDI
- Model / Reference
- MD1105.07 CataRhex 3 Ophthalmic Surgery System EUDAMEDVC821100 EUDAMEDFDA UDI
- Description
- CATARHEX 3 PHAKO GERÄT; CATARHEX 3 PHACO UNIT; CATARHEX 3 APPAREIL PHACO FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630003910445 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300039MD110507TP EUDAMED
- Direct Marketing DI
- 07630003910445 EUDAMED
- FDA Product Code
- HQC FDA UDI
- EMDN Code
- Q020499,Q020699 EUDAMED
- GMDN Term
- Phacoemulsification system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 886.4670 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
CataRhex 3 surgical platform, anterior by Oertli Instrumente Ag — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 76300039MD110507TP | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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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 f9dbca25-bd81-43be-8da0-c280eea8e547 61 fields · synced Jul 10, 2026
- FDA UDI ebdcdc96-c7ba-40a7-9aad-4bd70564b56b 34 fields · synced May 30, 2026
- EUDAMED a8189b04-ee44-453f-9fe0-70c5827a812a 61 fields · synced Jul 10, 2026