THERMO SHANDON LIMITED

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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

Slide Stainer, Automated (KPA) (5) Dispensers, Paraffin (IDW) (3) Processor, Tissue, Automated (IEO) (2)

Premarket Exempt

Yes

Clear

Thermo Fisher - 05051663002431 Catalog Number :

Device Description : 220-240V 50/60HZ (CHINA ONLY)

Device Class : 1

Duns Number: 219103512

Premarket Exempt : Yes

Product Code : IDW

Prescription Use : No

Device Count : 1

Thermo Fisher - 05051663002448 Catalog Number :

Device Class : 1

Duns Number: 219103512

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : No

Device Count : 1

Thermo Fisher - 05051663002561 Catalog Number :

Device Class : 1

Duns Number: 219103512

Premarket Exempt : Yes

Product Code : IDW

Prescription Use : No

Device Count : 1

Thermo Fisher - 05051663002578 Catalog Number :

Device Description : 220-240V 50/60HZ (CHINA ONLY)

Device Class : 1

Duns Number: 219103512

Premarket Exempt : Yes

Product Code : IDW

Prescription Use : No

Device Count : 1

Thermo Fisher - 05051663002950 Catalog Number :

Device Description : HEATED

Device Class : 1

Duns Number: 219103512

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : No

Device Count : 1

Thermo Fisher - 05051663002967 Catalog Number :

Device Description : UNHEATED

Device Class : 1

Duns Number: 219103512

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : No

Device Count : 1

Thermo Fisher - 05051663002974 Catalog Number :

Device Description : HEATED CHINA ONLY

Device Class : 1

Duns Number: 219103512

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : No

Device Count : 1

Thermo Fisher - 05051663002981 Catalog Number :

Device Description : UNHEATED CHINA ONLY

Device Class : 1

Duns Number: 219103512

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : No

Device Count : 1

Thermo Fisher - 05051663002998 Catalog Number :

Device Description : 100-240V 50/60HZ

Device Class : 1

Duns Number: 219103512

Premarket Exempt : Yes

Product Code : IEO

Prescription Use : No

Device Count : 1

Thermo Fisher - 05051663003001 Catalog Number :

Device Description : 100-240V 50/60Hz (CHINA ONLY)

Device Class : 1

Duns Number: 219103512

Premarket Exempt : Yes

Product Code : IEO

Prescription Use : No

Device Count : 1

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