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21 device results listed.

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Medonic M-series M32 B

Medonic M-series M32

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boule Medical AB
Manufacturer SRN: SE-MF-000001911
UDI-DI: 07350040796153
Basic UDI-DI: 735004079A001Y6
Reference: 1420021
EMDN: W0202010201
EMDN description: AUTOMATED 3 PART HEMATOLOGY ANALYSERS
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:51

Manufacturer products View details

Medonic M-serie Diluent 20L

Medonic M-series reagents

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Boule Medical AB
Manufacturer SRN: SE-MF-000001911
UDI-DI: 07350040794043
Basic UDI-DI: 735004079A012YB
Reference: 1504122
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:51

Manufacturer products View details

Swelab Alfa Plus Basic

Swelab Alfa Plus

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boule Medical AB
Manufacturer SRN: SE-MF-000001911
UDI-DI: 07350040791172
Basic UDI-DI: 735004079A002Y8
Reference: 1420041
EMDN: W0202010201
EMDN description: AUTOMATED 3 PART HEMATOLOGY ANALYSERS
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:51

Manufacturer products View details

Micro pipette, plastic EDTA 1x100

Boule Micropipettes

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Boule Medical AB
Manufacturer SRN: SE-MF-000001911
UDI-DI: 07350040790687
Basic UDI-DI: 735004079A009YN
Reference: 1070039
EMDN: W0501010203
EMDN description: BLOOD COLLECTION, CAPILLARY TUBES
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:51

Manufacturer products View details

Swelab AlfaDiluent, 900 cycles

Swelab Alfa reagents

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Boule Medical AB
Manufacturer SRN: SE-MF-000001911
UDI-DI: 07350040790175
Basic UDI-DI: 735004079A013YD
Reference: 1504124
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:51

Manufacturer products View details

Swelab AlfaLyse, 900 cycles

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Boule Medical AB
Manufacturer SRN: SE-MF-000001911
UDI-DI: 07350040790182
Basic UDI-DI: 735004079A013YD
Reference: 1504125
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 10:22

Manufacturer products View details

Swelab Alfa ComboPack 200

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Boule Medical AB
Manufacturer SRN: SE-MF-000001911
UDI-DI: 07350040790304
Basic UDI-DI: 735004079A013YD
Reference: 1504127
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 10:22

Manufacturer products View details

Swelab Alfa Plus Standard

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boule Medical AB
Manufacturer SRN: SE-MF-000001911
UDI-DI: 07350040791189
Basic UDI-DI: 735004079A002Y8
Reference: 7350040791189
EMDN: W0202010201
EMDN description: AUTOMATED 3 PART HEMATOLOGY ANALYSERS
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 10:22

Manufacturer products View details

Swelab Alfa Plus Cap AR

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boule Medical AB
Manufacturer SRN: SE-MF-000001911
UDI-DI: 07350040791202
Basic UDI-DI: 735004079A002Y8
Reference: 1420044
EMDN: W0202010201
EMDN description: AUTOMATED 3 PART HEMATOLOGY ANALYSERS
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 10:22

Manufacturer products View details

Swelab Alfa Plus Sampler BD AR

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boule Medical AB
Manufacturer SRN: SE-MF-000001911
UDI-DI: 07350040791226
Basic UDI-DI: 735004079A002Y8
Reference: 1420046
EMDN: W0202010201
EMDN description: AUTOMATED 3 PART HEMATOLOGY ANALYSERS
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 10:22

Manufacturer products View details

Medonic M-series Lyse, 5L

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Boule Medical AB
Manufacturer SRN: SE-MF-000001911
UDI-DI: 07350040794050
Basic UDI-DI: 735004079A012YB
Reference: 1504123
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 10:22

Manufacturer products View details

Medonic M-series Dual-pack

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Boule Medical AB
Manufacturer SRN: SE-MF-000001911
UDI-DI: 07350040794067
Basic UDI-DI: 735004079A012YB
Reference: 1504128
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 10:22

Manufacturer products View details

Medonic M-series M32 M

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boule Medical AB
Manufacturer SRN: SE-MF-000001911
UDI-DI: 07350040796160
Basic UDI-DI: 735004079A001Y6
Reference: 1420022
EMDN: W0202010201
EMDN description: AUTOMATED 3 PART HEMATOLOGY ANALYSERS
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 10:22

Manufacturer products View details

Medonic M-series M32 C AR

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boule Medical AB
Manufacturer SRN: SE-MF-000001911
UDI-DI: 07350040796184
Basic UDI-DI: 735004079A001Y6
Reference: 1420024
EMDN: W0202010201
EMDN description: AUTOMATED 3 PART HEMATOLOGY ANALYSERS
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 10:22

Manufacturer products View details

Medonic M-series M32 S BD AR

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boule Medical AB
Manufacturer SRN: SE-MF-000001911
UDI-DI: 07350040796207
Basic UDI-DI: 735004079A001Y6
Reference: 1420026
EMDN: W0202010201
EMDN description: AUTOMATED 3 PART HEMATOLOGY ANALYSERS
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 10:22

Manufacturer products View details

Medonic M-series Diluent, RFID

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Boule Medical AB
Manufacturer SRN: SE-MF-000001911
UDI-DI: 07350040796283
Basic UDI-DI: 735004079A012YB
Reference: 1504460
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 10:22

Manufacturer products View details

Medonic M-series Lyse, RFID

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Boule Medical AB
Manufacturer SRN: SE-MF-000001911
UDI-DI: 07350040796290
Basic UDI-DI: 735004079A012YB
Reference: 1504461
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 10:22

Manufacturer products View details

Swelab AlfaDiluent, RFID

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Boule Medical AB
Manufacturer SRN: SE-MF-000001911
UDI-DI: 07350040796306
Basic UDI-DI: 735004079A013YD
Reference: 1504462
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 10:22

Manufacturer products View details

Swelab AlfaLyse, RFID

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Boule Medical AB
Manufacturer SRN: SE-MF-000001911
UDI-DI: 07350040796313
Basic UDI-DI: 735004079A013YD
Reference: 1504463
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 10:22

Manufacturer products View details

Swelab Alfa ComboPack, RFID

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Boule Medical AB
Manufacturer SRN: SE-MF-000001911
UDI-DI: 07350040796320
Basic UDI-DI: 735004079A013YD
Reference: 1504464
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 10:22

Manufacturer products View details