TOKYO BOEKI MEDISYS INC.

TOKYO BOEKI MEDISYS INC.

Address:1-14-21 Higashi-Toyoda,Hino Tokyo,JP

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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

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use (JJE) (10)

Premarket Exempt

No

Clear

Alkaline Washing Solution - 04580262010208 Catalog Number : SP2208

Device Class : 1

Duns Number: 696265656

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

Acid Washing Solution - 04580262010222 Catalog Number : SP2209

Device Class : 1

Duns Number: 696265656

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

Na Electrode - 04580262010260 Catalog Number : 20-27-0474F

Device Class : 1

Duns Number: 696265656

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

K Electrode - 04580262010277 Catalog Number : 20-27-0475F

Device Class : 1

Duns Number: 696265656

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

Cl Electrode - 04580262010284 Catalog Number : 20-27-0476F

Device Class : 1

Duns Number: 696265656

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

Reference Electrode - 04580262010291 Catalog Number : 20-27-0473F

Device Class : 1

Duns Number: 696265656

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

Calibrator 1 - 04580262010307 Catalog Number : 20-27-0477F

Device Class : 1

Duns Number: 696265656

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

Urine Calibrator Set - 04580262010338 Catalog Number : 20-27-0480

Device Class : 1

Duns Number: 696265656

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

Diluent for Urine - 04580262010345 Catalog Number : 20-27-0482

Device Class : 1

Duns Number: 696265656

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

Dialysis Calibrator - 04580262010352 Catalog Number : 20-27-0483F

Device Class : 1

Duns Number: 696265656

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

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