Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3001061128

FEI Number

3001061128

Entity Name

BELIMED AG

City/State/Country

Zug, CH

Establishment Address

Grienbachstrasse 11, Zug 6300, CH

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Belimed AG (Owner Number: 10052111)

Owner / Operator Contact Address

Grienbachstrasse 11, Zug, CH-ZG 6300, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K170228

PMA Number

N/A

All Registered Proprietary Names

Belimed TOP 5000 Series 24. GR15-6-18HS1/GR15-6-18HS2 WD 750 WD200, WD230, WD250, WD290, WD390 WD 290 IQ CS 750, Cart Washer MST-V Models 6-0-6VS1/VS2, 6-0-9VS1/VS2, 6-0-12VS1/VS2 Sonic Systems HL Series MST-H TOP 5000 Belimed Steam Sterilizer MST-H, Models: MST-H 9-6-12 HS1/HS2 MST-H 9-6-15 HS1/HS2 MST-H 9-6-18 HS1/HS2 Belimed TOP 5000. 9-6-9HS1/HS2, GR9-6-9HS1/HS2, 9-6-12HS1/HS2, GR9-6-12HS1/HS2, 9-6-15HS1/HS2, GR9-6-15HS1/HS2, 9-6-18HS1/HS2, GR9-6-18HS1/HS2 MST-V 612 VS1/VS2 Belimed Steam Sterilizer MST-H Top 5000

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2016-06-15
MEC	Disinfector, Medical Devices	General Hospital	Class 2	880.6992	2016-06-15
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2016-06-15
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2023-05-05
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2019-11-26
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2016-06-15
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2016-06-15
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2016-06-15
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2018-11-27

Official Correspondent

Heidi Friesacher

US Agent Details

Steven Sutton Business: SteelcoBelimed Inc. Email: steven.sutton@belimed.com Phone: (843) 6074608

Related Public Records

Same Entity

Belimed AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010653034	BELIMED D.O.O.	Grosuplje, SI

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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0016-2026	Getinge Disinfection Ab Ljungadalsgatan	2	Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
Z-0018-2014	Getinge Disinfection Ljungadalsgatan	2	Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The washer disinfector is used in healthcare facilities where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
Z-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

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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 3001061128. Last updated year: 2026. Please use registration number 3001061128 when referencing this establishment in official correspondence.