Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013300766

FEI Number

3013300766

Entity Name

REMEDA AB

City/State/Country

Halmstad Halland, SE

Establishment Address

Transportvagen 8, Halmstad Halland 30230, SE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Remeda AB (Owner Number: 10060619)

Owner / Operator Contact Address

Transportvagen 8, Halmstad, SE-N 30272, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AUTOMATIC LOADER UNLOADER FOR RACK ALUS Evolution Automatic Loading System (ALUS)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2019-06-13
PEC	Sterilizer Automated Loading System	General Hospital	Class 2	880.6880	2022-03-10
PEC	Sterilizer Automated Loading System	General Hospital	Class 2	880.6880	2022-03-07

Official Correspondent

Joel Svensson

US Agent Details

Becky Aldhizer Business: STERIS Corporation Email: Becky_Aldhizer@steris.com Phone: (440) 3927490

Related Public Records

Same Entity

Remeda AB

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

Similar Registrations

Registration Number	Establishment Name	Location
1219189	CONSOLIDATED MACHINE CORP.	Billerica, MA, US
3005899764	STERIS MEXICO, S. de R.L. de C.V.	GUADALUPE Nuevo Leon, MX
8030087	TUTTNAUER LTD.	BEIT SHEMESH Jerusalem, IL
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 3013300766. Last updated year: 2026. Please use registration number 3013300766 when referencing this establishment in official correspondence.