Identity
- Trade Name
- MOBILE PATIENT BED EUDAMEDFDA UDI
- Generic Name
- Ophthalmic operating table, electromechanical FDA UDI
- Device Name
- CATALYS SYSTEM MOBILE PATIENT BED EUDAMEDMOBILE PATIENT BED FDA UDI
- Model / Reference
- 0160-6000 EUDAMEDFDA UDI
- Description
- MOBILE PATIENT BED FDA UDI
Identifiers
- Catalog Number
- 0160-6000 FDA UDI
- Primary DI / UDI-DI
- 05050474611764 EUDAMEDFDA UDI
- Basic UDI-DI
- 5050474a00069A4 EUDAMED
- Direct Marketing DI
- 05050474611764 EUDAMED
- FDA Product Code
- FQO FDA UDI
- EMDN Code
- Q020680 PHACOEMULSIFICATION DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Ophthalmic operating table, electromechanical FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4960 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Mobile Patient Bed 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 | 5050474a00069A4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- AMO Manufacturing USA, LLC
- EUDAMED SRN
- US-MF-000023322
- Authorised Representative
- AMO Ireland IE-AR-000013513
Sources (3)
- EUDAMED b10c674f-4c05-4be4-bb52-8dad860dbc9a 61 fields · synced Jun 19, 2026
- FDA UDI 5886a2d7-f0c3-497e-80a1-d1a02eb05a7a 36 fields · synced May 30, 2026
- EUDAMED 73650410-1b86-4568-bf79-a202e6ecbdc7 61 fields · synced Jun 19, 2026