Identity
- Trade Name
- PATIENT CHAIR EUDAMEDCATALYS PATIENT CHAIR FDA UDI
- Generic Name
- Femtosecond ophthalmic solid-state laser system FDA UDI
- Device Name
- CATALYS PATIENT CHAIR EUDAMEDPATIENT CHAIR FDA UDI
- Model / Reference
- 0160-6030 EUDAMEDFDA UDI
- Description
- PATIENT CHAIR FDA UDI
Identifiers
- Catalog Number
- 0160-6030 FDA UDI
- Primary DI / UDI-DI
- 05050474617193 EUDAMEDFDA UDI
- Basic UDI-DI
- 5050474a000079E EUDAMED
- Direct Marketing DI
- 05050474617193 EUDAMED
- FDA Product Code
- HMD FDA UDI
- EMDN Code
- Z12120280 THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Femtosecond ophthalmic solid-state laser system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1140 FDA UDI
- Market of Registration
- Ireland 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Patient Chair by AMO Manufacturing USA, LLC — Class I — 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 | 5050474a000079E | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 (3)
- EUDAMED 9c14fd4c-09b4-4f5b-b102-6c268a68a1f9 61 fields · synced Jul 24, 2026
- FDA UDI 24b6fcd7-b30d-4711-9ce2-8eea6a9a2d79 35 fields · synced May 26, 2026
- EUDAMED 39659ed1-1539-424f-af46-7c72bafe4832 61 fields · synced Jul 24, 2026