Identity
- Trade Name
- DI C500 FDA UDI
- Generic Name
- General-purpose surgical microscope FDA UDI
- Device Name
- DI C500, Dual Imaging Color module. FL - Accessory for Leica surgical operating microscope systems FDA UDI
- Model / Reference
- 000000000010448306 FDA UDI
- Description
- DI C500, Dual Imaging Color module. FL - Accessory for Leica surgical operating microscope systems FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630003556803 FDA UDI
- FDA Product Code
- EPT FDA UDI
- GMDN Term
- General-purpose surgical microscope FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General-purpose surgical microscope
Di C500 by Leica Microsystems (Schweiz) AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Leica Microsystems (Schweiz) AG
Sources (1)
- FDA UDI 08de3df1-4da4-4433-9166-53f047691837 36 fields · synced May 30, 2026