Identity
- Trade Name
- SeeLuma Digital Binoculars Upgrade Kit FDA UDI
- Generic Name
- Ophthalmic surgical microscope FDA UDI
- Device Name
- SeeLuma Digital Binoculars Upgrade Kit is an accessory for the surgical microscope SeeLuma. FDA UDI
- Model / Reference
- V12203-01 FDA UDI
- Description
- SeeLuma Digital Binoculars Upgrade Kit is an accessory for the surgical microscope SeeLuma. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04064434000155 FDA UDI
- FDA Product Code
- HRM FDA UDI
- GMDN Term
- Ophthalmic 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: Ophthalmic surgical microscope
SeeLuma Digital Binoculars Upgrade Kit by Munich Surgical Imaging GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Munich Surgical Imaging GmbH
Sources (2)
- FDA UDI d530e2e0-72e2-460b-9d76-f4289626c0df 33 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026