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Patient Support System LSCneo
EUDAMEDFDA UDIClass I (EU MDR)
Ref 636.000004Model Patient Support System
Identity
- Trade Name
- Patient Support System LSCneo EUDAMEDAKRUS FDA UDI
- Generic Name
- Ophthalmic operating table, electromechanical FDA UDI
- Device Name
- Laser Surgery Operating Table EUDAMED
- Model / Reference
- Patient Support System EUDAMED636.000004 EUDAMEDPatient Support System LSCneo FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260647943573 EUDAMEDFDA UDI
- Basic UDI-DI
- 426064794LSCLASER_OPEG EUDAMED
- Direct Marketing DI
- 04260647943573 EUDAMED
- FDA Product Code
- FQO FDA UDI
- EMDN Code
- Z12011202 OPERATING TABLES 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
- Germany 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
No
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
Yes
FDA UDI
Patient Support System LSCneo by AKRUS GmbH & Co. KG — 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 | 426064794LSCLASER_OPEG | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- AKRUS GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005262
Sources (3)
- EUDAMED 3d985bee-5980-4dd3-b6bb-f4633a4a140e 61 fields · synced Jul 8, 2026
- FDA UDI 771eedfc-d423-4497-9fdd-fabe9cb52475 32 fields · synced May 30, 2026
- EUDAMED b14cda1e-182d-4c6f-b3a1-27476296f34d 61 fields · synced Jun 18, 2026