Identity
- Trade Name
- Zvu FDA UDI
- Generic Name
- Manometric gastrointestinal motility analysis system FDA UDI
- Device Name
- Zvu® Advanced GI Diagnostic Software FDA UDI
- Model / Reference
- ZVU-2016 FDA UDI
- Description
- Zvu® Advanced GI Diagnostic Software FDA UDI
Identifiers
- Catalog Number
- ZVU-2016 FDA UDI
- Primary DI / UDI-DI
- 00816734022429 FDA UDI
- FDA Product Code
- FFX FDA UDI
- GMDN Term
- Manometric gastrointestinal motility analysis system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1725 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
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Manometric gastrointestinal motility analysis system
Zvu by Diversatek Healthcare — Class II — 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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Diversatek Healthcare
Sources (2)
- FDA UDI 56aabffd-c017-4832-a380-9479bca1bdf0 35 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced Jun 2, 2026