boule.comMEDONIC M SERIES
BOULE MEDICAL AB
BOULE MEDICAL AB
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3004008703 | 3004008703 | BOULE MEDICAL AB | 1 | N | 2026-01-01 | Fagerstagatan 7 Spanga Stockholm SE 163 53 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 07350040790250 | Micro pipette, plastic EDTA - Accessory for the MPA use in Medonic M-series, Swelab Alfa-series, and Boule 950-series hematology analyzer for blood collection from a finger stick or a venous blood sample and direct insertion into the Micro Pipette Adapter (MPA) inlet of Medonic M-series, Swelab Alfa-series, and Boule 950-series automated hematology analyzers. | 1800-453-3328 | qualitygroup@boule.com |
| 07350040790687 | Micro pipette, plastic EDTA - Accessory for the MPA use in Medonic M-series, Swelab Alfa-series, and Boule 950-series hematology analyzer for blood collection from a finger stick or a venous blood sample and direct insertion into the Micro Pipette Adapter (MPA) inlet of Medonic M-series, Swelab Alfa-series, and Boule 950-series automated hematology analyzers. | 1800-453-3328 | qualitygroup@boule.com |
| 07350040791417 | Boule EasyCleaner - Boule EasyCleaner is an accessory intended for regular cleaning and maintenance of Medonic M51/Swelab Lumi inlet and fluidic system | 1800-453-3328 | qualitygroup@boule.com |
| 07350040796399 | Medonic M51-D Diluent - The reagents are accessories intended to be used in combination with the Medonic M51.The diluent dilutes the blood sample to enable counting and sizing of red blood cells and platelets. | 1800-453-3328 | qualitygroup@boule.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 17840 | 1779218834 | K083420 | MEDONIC M SERIES | GKZ | 2009-02-03 |
| 17840 | 1546643340 | K032214 | MEDONIC CA620/530 HEMATOLOGY ANALYZER | GKZ | 2004-01-29 |
| 17840 | 1013738339 | ||||
| 17840 | 1076950410 | ||||
| 17840 | 1118945928 | ||||
| 17840 | 1204479306 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GKZ | 2 | 2009-02-03 |
PMN#
GUDID#
Micro pipette, plastic EDTA - Accessory for the MPA use in Medonic M-series, Swelab Alfa-series, and Boule 950-series hematology analyzer for blood collection from a finger stick or a venous blood sample and direct insertion into the Micro Pipette Adapter (MPA) inlet of Medonic M-series, Swelab Alfa-series, and Boule 950-series automated hematology analyzers.
2024-10-04
Micro pipette, plastic EDTA - Accessory for the MPA use in Medonic M-series, Swelab Alfa-series, and Boule 950-series hematology analyzer for blood collection from a finger stick or a venous blood sample and direct insertion into the Micro Pipette Adapter (MPA) inlet of Medonic M-series, Swelab Alfa-series, and Boule 950-series automated hematology analyzers.
2024-10-04
Boule EasyCleaner - Boule EasyCleaner is an accessory intended for regular cleaning and maintenance of Medonic M51/Swelab Lumi inlet and fluidic system
2024-10-04
Medonic M51-D Diluent - The reagents are accessories intended to be used in combination with the Medonic M51.The diluent dilutes the blood sample to enable counting and sizing of red blood cells and platelets.
2024-10-04
Medonic M51-L1 Lyse - The reagents are accessories intended to be used in combination with the Medonic M51.The lyse reagents lyses the red blood cells and maintain the morphology of white blood cells enabling sizing and counting of white blood cells and measurement of hemoglobin release from lysed red blood cells.
2024-10-04
Medonic M51-L2 Lyse - The reagents are accessories intended to be used in combination with the Medonic M51.The lyse reagents lyses the red blood cells and maintain the morphology of white blood cells enabling sizing and counting of white blood cells and measurement of hemoglobin release from lysed red blood cells.
2024-10-04
Swelab Lumi-D Diluent - The reagents are accessories intended to be used in combination with the Swelab Lumi.The diluent dilutes the blood sample to enable counting and sizing of red blood cells and platelets.
2024-10-04
Swelab Lumi-L1 Lyse - The reagents are accessories intended to be used in combination with the Swelab Lumi analyzer.The lyse reagents lyses the red blood cells and maintain the morphology of white blood cells enabling sizing and counting of white blood cells and measurement of hemoglobin release from lysed red blood cells
2024-10-04
Swelab Lumi-L2 Lyse - The reagents are accessories intended to be used in combination with the Swelab Lumi analyzer.The lyse reagents lyses the red blood cells and maintain the morphology of white blood cells enabling sizing and counting of white blood cells and measurement of hemoglobin release from lysed red blood cells
2024-10-04
Medonic M-series - A fully automatic, 3-part differential, hematology analyzer intended for in vitro diagnostic testing of blood specimens under laboratory conditions
2016-09-17
Medonic M-series - A fully automatic, 3-part differential, hematology analyzer intended for in vitro diagnostic testing of blood specimens under laboratory conditions
2016-09-17
Medonic M-series - A fully automatic, 3-part differential, hematology analyzer intended for in vitro diagnostic testing of blood specimens under laboratory conditions
2016-09-17
Medonic M-series - A fully automatic, 3-part differential, hematology analyzer intended for in vitro diagnostic testing of blood specimens under laboratory conditions.
2016-09-17