← Back to catalogue
Sterilization Tray Registration 2d C-Arm
EUDAMEDFDA UDIClass I (EU MDR)
Ref 52301
by Brainlab SE
Identity
- Trade Name
- STERILIZATION TRAY REGISTRATION 2D C-ARM EUDAMEDFDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- STERILIZATION TRAY EUDAMED
- Model / Reference
- 52301 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481122898 EUDAMEDFDA UDI
- Basic UDI-DI
- 4056481SteriTrayRF EUDAMED
- Direct Marketing DI
- 04056481122898 EUDAMED
- 510(k) Number
- K252562 FDA UDI
- FDA Product Code
- OLO FDA UDI
- EMDN Code
- S010499 STERILISATION CONTAINERS - OTHER EUDAMED
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Sterilization Tray Registration 2d C-Arm 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 | 4056481SteriTrayRF | 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 7c3c129c-0c0f-4bf9-a0a2-2d584abdfefd 61 fields · synced Aug 5, 2026
- FDA UDI 6ffb880c-18a9-4990-8c9d-6d9e92da5b2c 34 fields · synced May 30, 2026