ENBIO GROUP AG

FDA Device Registration & Listing · Oensingen Solothurn, CH · Registration 3016777357

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3016777357
FEI Number
3016777357
Entity Name
ENBIO GROUP AG
City/State/Country
Oensingen Solothurn, CH
Establishment Address
Eichengasse 3, Oensingen Solothurn 4702, CH
Establishment Type(s)
Manufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Enbio Group AG (Owner Number: 10073617)
Owner / Operator Contact Address
Eichengasse 3, Oensingen, CH-SO 4702, CH
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K260254
PMA Number
N/A

All Registered Proprietary Names

Enbio S Enbio S Enbio PRO

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FLE Sterilizer, Steam General Hospital Class 2 880.6880 2026-05-05
FLE Sterilizer, Steam General Hospital Class 2 880.6880 2026-05-05
FLE Sterilizer, Steam General Hospital Class 2 880.6880 2026-04-24

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Enbio Group AG
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K021223 Sauter AG BELIMED STEAM STERILIZER, MODEL TOP 5000 2002-06-26
K050263 M.O. Com S.R.L. MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU 2006-11-21

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016777357. Last updated year: 2026. Please use registration number 3016777357 when referencing this establishment in official correspondence.
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