This page includes the latest FDA filings for Belimed Ag. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3010653034 |
| FEI Number | 3010653034 |
| Name | BELIMED D.O.O. |
| Owner & Operator | Belimed AG |
| Contact Address | Grienbachstrasse 11 Zug CH-ZG Zug 6300 CH |
| Official Correspondent |
|
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | Taborska cesta 38 E Grosuplje Grosuplje, 1290 SI |
| Establishment Type | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Registration Number | 3001061128 |
| FEI Number | 3001061128 |
| Name | Sean Colwell |
| Owner & Operator | Belimed AG |
| Contact Address | Grienbachstrasse 11 Zug CH-ZG Zug 6300 CH |
| Official Correspondent |
|
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 8351 Palmetto Commerce Parkway Ste 101 Ladson Ladson, SC 29456 US |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
Device Company | Device | Date |
|---|---|---|
Sean Colwell [Belimed AG] | MST-H TOP 5000 | 2019-11-26 |
BELIMED D.O.O. [Belimed AG] | MST-H TOP 5000 | 2019-11-26 |
Belimed AG | Belimed Steam Sterilizer MST-H TOP 5000 | 2019-10-31 |
| Belimed AG | NA NA | 2019-03-19 |
| Belimed AG | 2019-03-19 | |
| Belimed AG | 2019-03-19 | |
| Belimed AG | 2019-03-19 | |
| Belimed AG | 2019-03-19 | |
| Belimed AG | 2019-03-19 | |
| Belimed AG | 2019-03-19 | |
| Belimed AG | 2019-03-19 | |
| Belimed AG | 2019-03-19 | |
Sean Colwell [Belimed AG] | Belimed Steam Sterilizer MST-H Top 5000 | 2018-11-27 |
BELIMED D.O.O. [Belimed AG] | Belimed Steam Sterilizer MST-H Top 5000 | 2018-11-27 |
Belimed AG | Belimed Steam Sterilizer MST-H TOP 5000 | 2017-05-12 |
BELIMED D.O.O. [Belimed AG] | MST-H 9-6-12 HS1/HS2 MST-H 9-6-15 HS1/HS2 MST-H 9-6-18 HS1/HS2 | 2016-12-20 |
BELIMED D.O.O. [Belimed AG] | MST-V Models 6-0-6VS1/VS2, 6-0-9VS1/VS2, 6-0-12VS1/VS2 | 2016-12-20 |
BELIMED D.O.O. [Belimed AG] | MST-V 3-3-6 VS1/VS2 | 2016-12-20 |
BELIMED D.O.O. [Belimed AG] | MST-V 612 VS1/VS2 | 2016-12-20 |
BELIMED D.O.O. [Belimed AG] | Belimed TOP 5000 Series 24. GR15-6-18HS1/GR15-6-18HS2 | 2016-12-20 |
BELIMED D.O.O. [Belimed AG] | Belimed TOP 5000 Series 5-5-9VS1/VS2, 5-0-9VS1/VS2 | 2016-12-20 |
BELIMED D.O.O. [Belimed AG] | Belimed TOP 5000 Series 4-8. 6-0-6VS1/VS2, 6-0-9VS1/VS2, 6-0-12VS1/VS | 2016-12-20 |
BELIMED D.O.O. [Belimed AG] | 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 | 2016-12-20 |
Sean Colwell [Belimed AG] | 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 | 2016-06-15 |
Sean Colwell [Belimed AG] | MST-V Models 6-0-6VS1/VS2, 6-0-9VS1/VS2, 6-0-12VS1/VS2 | 2016-06-15 |
Sean Colwell [Belimed AG] | MST-V 3-3-6 VS1/VS2 | 2016-06-15 |
Sean Colwell [Belimed AG] | MST-V 612 VS1/VS2 | 2016-06-15 |
Sean Colwell [Belimed AG] | Belimed TOP 5000 Series 24. GR15-6-18HS1/GR15-6-18HS2 | 2016-06-15 |
Sean Colwell [Belimed AG] | Belimed TOP 5000 Series 5-5-9VS1/VS2, 5-0-9VS1/VS2 | 2016-06-15 |
Sean Colwell [Belimed AG] | Belimed TOP 5000 Series 4-8. 6-0-6VS1/VS2, 6-0-9VS1/VS2, 6-0-12VS1/VS2 | 2016-06-15 |
Sean Colwell [Belimed AG] | 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 | 2016-06-15 |
Sean Colwell [Belimed AG] | WD200, WD230, WD250, WD290, WD390 | 2016-06-15 |
Sean Colwell [Belimed AG] | WD 750 | 2016-06-15 |
Sean Colwell [Belimed AG] | WD 290 IQ | 2016-06-15 |
BELIMED D.O.O. [Belimed AG] | WD750 | 2016-06-15 |
BELIMED D.O.O. [Belimed AG] | WD200, WD230, WD250, WD290, WD390 | 2016-06-15 |
BELIMED D.O.O. [Belimed AG] | WD 290 IQ | 2016-06-15 |
Sean Colwell [Belimed AG] | CS750, Cart Washer | 2016-06-15 |
BELIMED D.O.O. [Belimed AG] | CS 750 | 2013-12-30 |
| NCAGE Code | SK355 | BELIMED AG |
| CAGE Code | SK355 | BELIMED AG |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2020082621260 | Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey | SLAC RACK FOR GLASS WASHING MODULE 316L PIPETTE HS CODE 84229010 SCAC SSLL | 1 PKG |
| 2020082621258 | Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey | SLAC WASH RACKS FOR PH860.2 HS CODE 84229010 SCAC SSLL AMS REF NYC262597 | 2 CRT |
| 2020082524314 | Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey | SLAC RACK FOR GLASS WASHING MODULE 316L PIPETTE HS CODE 84229010 SCAC SSLL | 1 PKG |
| 202008257245 | Stadersand,Federal Republic of Germany -> Los Angeles, California | STERILIZATOR WA290 2RA CR92 AND PARTS HS CODE8428920 AMS REF LAX233067 SCAC SSLL | 7 PKG |
| 2020082524312 | Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey | SLAC WASH RACKS FOR PH860.2 HS CODE 84229010 SCAC SSLL AMS REF NYC262597 | 2 CRT |
| 2020082425728 | Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey | SLAC RACK FOR GLASS WASHING MODULE 316L PIPETTE HS CODE 84229010 SCAC SSLL | 1 PKG |
| 2020082425726 | Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey | SLAC WASH RACKS FOR PH860.2 HS CODE 84229010 SCAC SSLL AMS REF NYC262597 | 2 CRT |
| 2020082016050 | Stadersand,Federal Republic of Germany -> Los Angeles, California | STERILIZATOR WA290 2RA CR92 AND PARTS HS CODE8428920 AMS REF LAX233067 SCAC SSLL | 7 PKG |