ClearumTM HS
Bellco Srl
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1000312731 | 1000312731 | BELLCO Srl | 1 | N | 2026-01-01 | via Camurana, 1 Mirandola Modena IT 41037 |
| 1000312731 | 1000312731 | BELLCO Srl | 1 | N | 2020-04-25 | via Camurana, 1 Mirandola Modena IT 41037 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 08032979792282 | CARPEDIEM - BL 250 HEMOFILTRATION/HEMODIALYSIS KIT 015 FOR CARPEDIEM | +39053529111 | RegulatoryOperations@mozarcmedical.com |
| 08032979792299 | CARPEDIEM - BL 250 HEMOFILTRATION/HEMODIALYSIS KIT 025 FOR CARPEDIEM | +39053529111 | RegulatoryOperations@mozarcmedical.com |
| 08051736003768 | 3 L NON STERILE WASTE BAGS - IB0507009 | +39053529111 | RegulatoryOperations@mozarcmedical.com |
| 08051736004130 | CLEARUM HS - CLEARUM HS 13 High Flux dialyzer | +1(508)261-8000 | covidien.udi@covidien.com |
| 08051736004147 | CLEARUM HS - CLEARUM HS 15 High Flux dialyzer | +1(508)261-8000 | covidien.udi@covidien.com |
| 08051736004154 | CLEARUM HS - CLEARUM HS 17 High Flux dialyzer | +39053529111 | RegulatoryOperations@mozarcmedical.com |
| 08051736004161 | CLEARUM HS - CLEARUM HS 20 High Flux dialyzer | +39053529111 | RegulatoryOperations@mozarcmedical.com |
| 08051736004178 | CLEARUM HS - CLEARUM HS 22 High Flux dialyzer | +39053529111 | RegulatoryOperations@mozarcmedical.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 334708 | 1935563998 | K821537 | HENKE DISPOSABLE SYRINGE | FMF | 1982-05-28 |
| 334708 | 1965361291 | K231406 | ClearumTM HS | KDI | 2023-06-14 |
| 334708 | 1123561448 | K193542 | Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22 | KDI | 2020-10-08 |
| 175035 | 1185746028 | K160558 | RAPIDO HOLLOW-FIBRE DIALYZERS | KDI | 2016-11-18 |
| 334708 | 1969962216 | K121198 | BW685, BW685S | LGZ | 2012-07-12 |
| 334708 | 1464618595 | DEN180055 | CARPEDIEM System | QIR | 2020-04-29 |
| 334708 | 1896793969 |
Bellco Srl
Bellco Srl
BELLCO Srl
2020-06-17
2020-06-17
2021-05-30
2021-01-01
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2025-05-09
2020-05-20
2023-08-04
2021-05-30
2020-06-17
2020-06-17
2021-01-01
2021-01-01
2021-01-01
2021-01-01
2021-01-01