← Back to catalogue
Sterilization Tray ClearLens® Knee
EUDAMEDFDA UDIClass I (EU MDR)
Ref 52318A
by Brainlab SE
Identity
- Trade Name
- Sterilization Tray ClearLens® Knee EUDAMEDSterilization Tray for Knee3 ClearLens FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- Sterilization Tray (Ortho) EUDAMED
- Model / Reference
- 52318A EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 52318A FDA UDI
- Primary DI / UDI-DI
- 04056481140953 EUDAMEDFDA UDI
- Basic UDI-DI
- 4056481SteriTrayOrthoEP EUDAMED
- Direct Marketing DI
- 04056481140953 EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- Z12011380 CLEANING, DISINFECTION AND STERILISATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Sterilization Tray ClearLens® Knee by Brainlab SE — 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 | 4056481SteriTrayOrthoEP | 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
- Brainlab SE
- EUDAMED SRN
- DE-MF-000006183
Sources (2)
- EUDAMED 5e6ac8f9-b107-4a8d-a63a-baa0fb97c303 61 fields · synced Jun 19, 2026
- FDA UDI 607afb9f-5651-4aa3-bbfd-d2a784c5e4b3 35 fields · synced May 30, 2026