Identity
- Trade Name
- joimax® Vitegra® Control Unit EUDAMEDVitegra® FDA UDI
- Generic Name
- Medical image management system FDA UDI
- Device Name
- joimax® Vitegra® Control Unit EUDAMEDFDA UDI
- Model / Reference
- ICS0401 EUDAMEDFDA UDI
- Description
- joimax® Vitegra® Control Unit FDA UDI
Identifiers
- Catalog Number
- ICS0401 FDA UDI
- Primary DI / UDI-DI
- 04250337115281 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503371VIDOKH EUDAMED
- Direct Marketing DI
- 04250337115281 EUDAMED
- FDA Product Code
- LMB FDA UDI
- EMDN Code
- Z12020401 INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES EUDAMED
- GMDN Term
- Medical image management system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.2010 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
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: Medical image management system
Vitegra® by Joimax, Inc. — Class I — 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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Joimax, Inc.
Sources (2)
- FDA UDI 719b6575-d2e5-4cc6-8838-c20590a61d82 36 fields · synced Jun 19, 2026
- EUDAMED 934103e4-8472-431f-b450-f5634e3b590c 61 fields · synced Jun 19, 2026