Identity
- Trade Name
- SeeLuma FDA UDI
- Generic Name
- Ophthalmic surgical microscope FDA UDI
- Device Name
- The medical device is a surgical microscope designed for the illumination and magnification of the surgical area in ophthalmic surgeries. The system provides interfaces via which image, OCT and other data can be imported and exported. FDA UDI
- Model / Reference
- V12100-01 FDA UDI
- Description
- The medical device is a surgical microscope designed for the illumination and magnification of the surgical area in ophthalmic surgeries. The system provides interfaces via which image, OCT and other data can be imported and exported. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04064434000124 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
Yes
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 by Munich Surgical Imaging GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic surgical microscope.
- MOPTIM — Shenzhen CERTAINN Technology Co., Ltd. · Class I
- Dovetail for BIOM — OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung · Class I
- OPMI Lumera 700 — Carl Zeiss Meditec AG · Class I
- BIOM Connecting Spacer Leica CAN for BIOM 5c/cl — OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung · Class I
- LuxOR — Alcon Laboratories, Inc. · Class I
- LuxOR Revalia — Alcon Laboratories, Inc. · Class I
- MOPTIM — Shenzhen CERTAINN Technology Co., Ltd. · Class I
- Adapter plate Alcon REVALIA(TM) for BIOM 5/BIOM ready — OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Munich Surgical Imaging GmbH
Sources (1)
- FDA UDI 7b781f41-8afb-47ed-8648-b3d26d25ab62 33 fields · synced May 30, 2026