HYPHEN BIOMED

Address:155 RUE D ERAGNY,NEUVILLE SUR OISE Val-d'Oise,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

Plasma, Coagulation Control (GGN) (3) Antithrombin Iii Quantitation (JBQ) (2) Assay, Heparin (KFF) (2) Test, Qualitative And Quantitative Factor Deficiency (GGP) (2)

Premarket Exempt

No Yes

Clear

BIOPHEN LMWH Control C3 - 03663537007989 Catalog Number : 223801

Device Class : 2

Duns Number: 503499167

Premarket Exempt : No

Product Code : GGN

Prescription Use : No

Device Count : 1

BIOPHEN UFH CONTROL C2 - 03663537007996 Catalog Number : 223901

Device Class : 2

Duns Number: 503499167

Premarket Exempt : No

Product Code : GGN

Prescription Use : No

Device Count : 1

Imidazole buffer - 03663537008047 Catalog Number : AR021A

Device Class :

Duns Number: 503499167

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

BIOPHEN HEPARIN 3 - 03663537008184 Catalog Number : 221003

Device Class : 2

Duns Number: 503499167

Premarket Exempt : No

Product Code : KFF

Prescription Use : No

Device Count : 1

BIOPHEN HEPARIN 6 - 03663537008191 Catalog Number : 221006

Device Class : 2

Duns Number: 503499167

Premarket Exempt : No

Product Code : KFF

Prescription Use : No

Device Count : 1

BIOPHEN Antithrombin 2.5 - 03663537008207 Catalog Number : 221102

Device Class : 2

Duns Number: 503499167

Premarket Exempt : No

Product Code : JBQ

Prescription Use : No

Device Count : 1

BIOPHEN Antithrombin 5 - 03663537008214 Catalog Number : 221105

Device Class : 2

Duns Number: 503499167

Premarket Exempt : No

Product Code : JBQ

Prescription Use : No

Device Count : 1

BIOPHEN Protein C 2.5 - 03663537008221 Catalog Number : 221202

Device Class : 2

Duns Number: 503499167

Premarket Exempt : No

Product Code : GGP

Prescription Use : No

Device Count : 1

BIOPHEN Protein C 5 - 03663537008238 Catalog Number : 221205

Device Class : 2

Duns Number: 503499167

Premarket Exempt : No

Product Code : GGP

Prescription Use : No

Device Count : 1

BIOPHEN Heparin Calibrator - 03663537008245 Catalog Number : 222001

Device Class : 2

Duns Number: 503499167

Premarket Exempt : No

Product Code : GGN

Prescription Use : No

Device Count : 1

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