Identity
- Trade Name
- Enbio Data Viewer FDA UDI
- Generic Name
- Steam sterilizer FDA UDI
- Device Name
- Software dedicated only to the Enbio autoclaves and created by our company. It will be a read-only, visualization software for carried out sterilization or test cycles. This software will not be a software necessary for the proper operation of the device and may not be used by the end user at all. Also will not give the possibility of any interference in the device operating parameters and records of sterilization or tests carried out. FDA UDI
- Model / Reference
- 17 FDA UDI
- Description
- Software dedicated only to the Enbio autoclaves and created by our company. It will be a read-only, visualization software for carried out sterilization or test cycles. This software will not be a software necessary for the proper operation of the device and may not be used by the end user at all. Also will not give the possibility of any interference in the device operating parameters and records of sterilization or tests carried out. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07629999504721 FDA UDI
- FDA Product Code
- FLE FDA UDI
- GMDN Term
- Steam sterilizer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6880 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
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Category: Steam sterilizer
Enbio Data Viewer by Enbio Group 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
- Enbio Group AG
Sources (1)
- FDA UDI 1c9af863-ce2d-43d6-9f4e-afd80960d2c8 34 fields · synced May 31, 2026