BIOLOG-ID

Address:1 rue du commandant Robert Malrait,Bernay Normandie,FR

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Refrigerator, Freezer, Blood Storage (KSE) (10)

Premarket Exempt

Yes

Clear

Kit SST-R 15 shelves 4x2 - B765PRD7130100 Catalog Number :

Device Description : Kit SST-R for the retrofitting of 15 shelves refrigerator 4 by 2 unit slots per shelves

Device Class : 2

Duns Number: 277828187

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

Kit SST-R 15 shelves 4x3 - B765PRD7130200 Catalog Number :

Device Description : Kit SST-R for the retrofitting of 15 shelves refrigerator 4 by 3 unit slots per shelves

Device Class : 2

Duns Number: 277828187

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

Kit SST-R 15 shelves 5x3 - B765PRD7130300 Catalog Number :

Device Description : Kit SST-R for the retrofitting of 15 shelves refrigerator 5 by 3 unit slots per shelves

Device Class : 2

Duns Number: 277828187

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

Kit SST-R 15 shelves 3x2 - B765PRD7130400 Catalog Number :

Device Description : Kit SST-R for the retrofitting of 15 shelves refrigerator 3 by 2 unit slots per shelves

Device Class : 2

Duns Number: 277828187

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

Kit SST-R 4 shelves 3x2 - B765PRD7130404 Catalog Number :

Device Description : Kit SST-R for the retrofitting of 4 shelves refrigerator 3 by 2 unit slots per shelves

Device Class : 2

Duns Number: 277828187

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

Kit SST-F 10 shelves V2 - B765PRD7140300 Catalog Number :

Device Description : Kit SST-F for the retrofitting of 10 shelves freezer

Device Class : 2

Duns Number: 277828187

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

Kit SST-A 30 for PF48 - B765PRD7150200 Catalog Number :

Device Description : Kit SST-A for the retrofitting of the Helmer PF48

Device Class : 2

Duns Number: 277828187

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

Kit SST-A 10 for PF96 - B765PRD7150300 Catalog Number :

Device Description : Kit SST-A for the retrofitting of the Helmer PF96 incubator

Device Class : 2

Duns Number: 277828187

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

Kit SST-A 10 for PC4200 - B765PRD7150400 Catalog Number :

Device Description : Kit SST-A for the retrofitting of the Helmer PC4200 incubator

Device Class : 2

Duns Number: 277828187

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

Kit SST-R HD 45cm ColdRoom - B765PRD7170100 Catalog Number :

Device Description : Kit SST-R HD for the retrofitting shelves of cold room 45cm

Device Class : 2

Duns Number: 277828187

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

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