Identity
- Trade Name
- BLUE LIGHT IMAGING UNIT FDA UDI
- Generic Name
- Software upgrade/unlocking key FDA UDI
- Model / Reference
- MAJ-2305 FDA UDI
Identifiers
- Catalog Number
- N5769640 FDA UDI
- Primary DI / UDI-DI
- 04953170396021 FDA UDI
- FDA Product Code
- EPT FDA UDI
- GMDN Term
- Software upgrade/unlocking key 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
No
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: Software upgrade/unlocking key
Blue Light Imaging Unit by Olympus Medical Systems Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Software upgrade/unlocking key.
- Pure Vue — Medos International Sàrl · Class II
- CHATTANOOGA — DJO, LLC · Class I
- Internal Battery PM Upgrade USB Drive — VENTEC LIFE SYSTEMS, INC. · Class II
- SWQ SOFTWARE OPTION — Olympus Medical Systems Corporation · Class II
- ELST SOFTWARE OPTION — Olympus Medical Systems Corporation · Class II
- CHE SOFTWARE OPTION — Olympus Medical Systems Corporation · Class II
- Infrared imaging unit — Olympus Medical Systems Corporation · Class I
- OTV-S500 UPGRADE PACK STROBE — Olympus Medical Systems Corporation · Class II
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
- Olympus Medical Systems Corporation
Sources (1)
- FDA UDI 192a5ea0-1e1a-4aa6-9fc2-faf276bbf5f0 34 fields · synced May 31, 2026