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Liquid Optics Interface
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 0180-1201Ref 0180-1401
Identity
- Trade Name
- LIQUID OPTICS INTERFACE EUDAMEDFDA UDI
- Generic Name
- Ophthalmic laser system beam guide FDA UDI
- Device Name
- CATALYS SYSTEM LIQUID OPTICS INTERFACE EUDAMEDLIQUID OPTICS INTERFACE, SIZE 14, GEN2 FDA UDILIQUID OPTICS INTERFACE, SIZE 12, GEN2 FDA UDI
- Model / Reference
- 0180-1201 EUDAMEDFDA UDI0180-1401 EUDAMEDFDA UDI
- Description
- LIQUID OPTICS INTERFACE, SIZE 14, GEN2 FDA UDILIQUID OPTICS INTERFACE, SIZE 12, GEN2 FDA UDI
Identifiers
- Catalog Number
- 0180-1401 FDA UDI0180-1201 FDA UDI
- Primary DI / UDI-DI
- 05050474609778 EUDAMEDFDA UDI05050474609761 EUDAMEDFDA UDI
- Basic UDI-DI
- 5050474a000099J EUDAMED
- FDA Product Code
- OOE FDA UDI
- EMDN Code
- Z12120285 THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Ophthalmic laser system beam guide FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.4390 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Liquid Optics Interface by AMO Manufacturing USA, LLC — Class IIa — 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 | 5050474a000099J | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- AMO Manufacturing USA, LLC
- EUDAMED SRN
- US-MF-000023322
- Authorised Representative
- AMO Ireland IE-AR-000013513
Sources (6)
- EUDAMED 0223c925-e84b-4284-9b2b-46f3b3107cb0 61 fields · synced Jul 20, 2026
- EUDAMED 509f8bd9-ec5c-4376-9e57-ffe3ae99b01b 61 fields · synced May 17, 2026
- FDA UDI a545b67f-ba7c-41a3-84b4-42f2f9cb1401 36 fields · synced May 30, 2026
- FDA UDI a9f3f82f-80ca-4dba-9a7f-404faf6cadd7 36 fields · synced May 30, 2026
- EUDAMED 5985661c-6a4e-4d83-b581-bc39fd1078a8 61 fields · synced Jul 9, 2026
- EUDAMED 364e598e-d6ea-48b2-98f4-b14566ea93d2 61 fields · synced Jul 20, 2026