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Sterilization Tray Varioguide® Aligment System
EUDAMEDFDA UDIClass I (EU MDR)
Ref 52303A
by Brainlab SE
Identity
- Trade Name
- STERILIZATION TRAY VARIOGUIDE® ALIGMENT SYSTEM EUDAMEDFDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- STERILIZATION TRAY EUDAMED
- Model / Reference
- 52303A EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 52303A FDA UDI
- Primary DI / UDI-DI
- 04056481143602 EUDAMEDFDA UDI
- Basic UDI-DI
- 4056481SteriTrayRF EUDAMED
- Direct Marketing DI
- 04056481143602 EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- S010499 STERILISATION CONTAINERS - OTHER 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
- 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Sterilization Tray Varioguide® Aligment System 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 |
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Manufacturer
- Manufacturer
- Brainlab SE
- EUDAMED SRN
- DE-MF-000006183
Sources (2)
- EUDAMED a1de661f-89c7-4207-98e0-54e17719e8ae 61 fields · synced Jul 13, 2026
- FDA UDI 8afe7bdf-6db1-493d-be43-78746bb7652e 34 fields · synced May 26, 2026