Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018815412

FEI Number

3018815412

Entity Name

ENBIO TECHNOLOGY SP. Z.O.O.

City/State/Country

Gdynia Pomorskie, PL

Establishment Address

Polnocna 10 Street, Gdynia Pomorskie PL-81-029, PL

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Enbio Technology Sp. z.o.o. (Owner Number: 10084687)

Owner / Operator Contact Address

Dzialkowcow 15 Street, Rumia, PL-NOTA PL-84-230, PL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Enbio PRO Enbio S

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2026-04-24
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2022-03-22

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 Technology Sp. z.o.o.

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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3022516928	DENT4YOU AG	Heerbrugg Sankt Gallen, CH
3012068831	Getinge IC Production Poland sp. z o.o.	Plewiska Wielkopolskie, PL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018815412. Last updated year: 2026. Please use registration number 3018815412 when referencing this establishment in official correspondence.