Identity
- Trade Name
- SafeID EUDAMEDFDA UDI
- Generic Name
- Patient-administration information system application software FDA UDI
- Device Name
- SafeID EUDAMEDSafeID 2.3 FDA UDI
- Model / Reference
- SafeID 2.3 EUDAMEDFDA UDI
- Description
- SafeID 2.3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05056190500801 EUDAMEDFDA UDI
- Basic UDI-DI
- 5056190500702UZ EUDAMED
- Direct Marketing DI
- 05056190500801 EUDAMED
- FDA Product Code
- OUG FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Patient-administration information system application software FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6310 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Northern Ireland 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: Device sterilization/disinfection container, reusable
SafeID by Vision RT Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5056190500702UZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Vision RT Ltd.
- EUDAMED SRN
- GB-MF-000010499
- Authorised Representative
- Oticon A/S DK-AR-000006135
Sources (2)
- EUDAMED 95a7b490-67f9-484c-93b6-9dfd5c0fbcef 61 fields · synced Jul 12, 2026
- FDA UDI d2ffa289-9c30-4a27-8fde-9c10c3dcf5eb 34 fields · synced May 29, 2026