Identity
- Trade Name
- CONVIVO FDA UDI
- Generic Name
- Scanning laser optical microscope FDA UDI
- Model / Reference
- 6918 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049539069184 FDA UDI
- FDA Product Code
- LLZ FDA UDIOWN FDA UDIGWG FDA UDI
- GMDN Term
- Scanning laser optical microscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI876.1500 FDA UDI882.1480 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Scanning laser optical microscope
Convivo by Carl Zeiss Meditec AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Scanning laser optical microscope.
- cCeLL — VPIX Medical, Inc. · Class I
- VivaScope System — Caliber Imaging & Diagnostics, Inc. · Class II
- VivaScope System — Caliber Imaging & Diagnostics, Inc. · Class II
- VivaScope 2500 — Caliber Imaging & Diagnostics, Inc. · Class I
- cCeLL — VPIX Medical, Inc. · Class I
- Affymetrix — Affymetrix, Inc. · Class II
Cleared under the same submission
K181116 also covers:
K211156 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Carl Zeiss Meditec AG
Sources (1)
- FDA UDI fcc75a21-02e9-445b-a331-67ac94ea3cd3 33 fields · synced May 31, 2026