Identity
- Trade Name
- FORUM FDA UDI
- Generic Name
- Patient health record information system application software FDA UDI
- Device Name
- Intended Use: FORUM is a software system intended for use in storage, management, processing, and display of patient, diagnostic, video and image data and measurement from computerized diagnostic instruments or documentation systems through networks. It is intended to work with other FORUM applications. FORUM is intended for use in review of patient, diagnostic and image data and measurement by trained healthcare professionals. FDA UDI
- Model / Reference
- 4 FDA UDI
- Description
- Intended Use: FORUM is a software system intended for use in storage, management, processing, and display of patient, diagnostic, video and image data and measurement from computerized diagnostic instruments or documentation systems through networks. It is intended to work with other FORUM applications. FORUM is intended for use in review of patient, diagnostic and image data and measurement by trained healthcare professionals. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049471070330 FDA UDI
- 510(k) Number
- K213527 FDA UDI
- FDA Product Code
- NFJ FDA UDI
- GMDN Term
- Patient health record information system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
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Manufacturing Date
Yes
FDA UDI
Category: Patient health record information system application software
Forum by Carl Zeiss Meditec AG — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Carl Zeiss Meditec AG
Sources (1)
- FDA UDI 696b132b-1174-4315-a254-8f9e04f5a01c 34 fields · synced May 30, 2026