Identity
- Trade Name
- Enbio FDA UDI
- Generic Name
- Steam sterilizer FDA UDI
- Device Name
- The Enbio S is an air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of dental and medical instruments that are validated to be sterilized by steam. The Enbio S has not been designed to sterilize liquid loads, bio-medical waste or materials not compatible with steam sterilization. FDA UDI
- Model / Reference
- Enbio S Beauty FDA UDI
- Description
- The Enbio S is an air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of dental and medical instruments that are validated to be sterilized by steam. The Enbio S has not been designed to sterilize liquid loads, bio-medical waste or materials not compatible with steam sterilization. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07629999190788 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Steam sterilizer
Enbio by Enbio Group AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Steam sterilizer.
- Flight Dental Systems — FLIGHT DENTAL SYSTEMS USA INC. · Class II
- AMSCO — Steris Mexico, S. de R.L. de C.V. · Class II
- STATIM 5000 G4 Cassette Autoclave — Scican GmbH · Class II
- Integrity Sterilizers — Skytron, LLC · Class II
- Getinge 500 Series — GETINGE IC PRODUCTION POLAND SP Z O O · Class II
- PRIMUS Sterilizer — PRIMUS STERILIZER COMPANY, LLC. · Class II
- AMSCO — Steris Mexico, S. de R.L. de C.V. · Class II
- AG Neovo — ASSOCIATED INDUSTRIES CHINA, INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Enbio Group AG
Sources (1)
- FDA UDI 2e938f3c-6be6-45d1-b8a0-ca8bf68d6521 34 fields · synced May 30, 2026