BELIMED D.O.O.

FDA Device Registration & Listing · Grosuplje, SI · Registration 3010653034

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
3010653034
FEI Number
3010653034
Entity Name
BELIMED D.O.O.
City/State/Country
Grosuplje, SI
Establishment Address
Taborska cesta 38 E, Grosuplje 1290, SI
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Belimed AG (Owner Number: 10045797)
Owner / Operator Contact Address
Grienbachstrasse 11, Zug, CH-ZG 6300, CH
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

MST-H 9-6-12 HS1/HS2 MST-H 9-6-15 HS1/HS2 MST-H 9-6-18 HS1/HS2 MST-V Models 6-0-6VS1/VS2, 6-0-9VS1/VS2, 6-0-12VS1/VS2

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FLE Sterilizer, Steam General Hospital Class 2 880.6880 2016-12-20
FLE Sterilizer, Steam General Hospital Class 2 880.6880 2016-12-20

Official Correspondent

No official correspondent registered.

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
3001061128 BELIMED AG Zug, CH

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 3010653034. Last updated year: 2026. Please use registration number 3010653034 when referencing this establishment in official correspondence.
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