Lepu Medical Technology (Beijing) Co.,Ltd.

Address:Building 5 & 6 No. 21 Courtyard, Panlong West Road,Beijing,CN

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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

Syringe, Balloon Inflation, Exempt (PTM) (10) Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (DTL) (8) Wire, Guide, Catheter, Exempt (PTL) (6)

Premarket Exempt

No Yes

Clear

Angioway - 06936733735886 Catalog Number :

Device Description : The inflation device is applied to inflate/deflate balloon catheters and monitor

Device Class : 2

Duns Number: 529853921

Premarket Exempt : Yes

Product Code : PTM

Prescription Use : Yes

Device Count : 1

Angioway - 06936733735893 Catalog Number :

Device Description : The inflation device is applied to inflate/deflate balloon catheters and monitor

Device Class : 2

Duns Number: 529853921

Premarket Exempt : Yes

Product Code : PTM

Prescription Use : Yes

Device Count : 1

Angioway - 06936733735923 Catalog Number :

Device Description : Inflation Device Kits is indicated for use in percutaneous coronary Intervention

Device Class : 2

Duns Number: 529853921

Premarket Exempt : Yes

Product Code : PTM, DTL, PTL

Prescription Use : Yes

Device Count : 1

Angioway - 06936733735930 Catalog Number :

Device Description : Inflation Device Kits is indicated for use in percutaneous coronary Intervention

Device Class : 2

Duns Number: 529853921

Premarket Exempt : Yes

Product Code : PTL, DTL, PTM

Prescription Use : Yes

Device Count : 1

Angioway - 06936733735947 Catalog Number :

Device Description : Inflation Device Kits is indicated for use in percutaneous coronary Intervention

Device Class : 2

Duns Number: 529853921

Premarket Exempt : Yes

Product Code : PTM, DTL, PTL

Prescription Use : Yes

Device Count : 1

Angioway - 06936733735954 Catalog Number :

Device Description : Inflation Device Kits is indicated for use in percutaneous coronary Intervention

Device Class : 2

Duns Number: 529853921

Premarket Exempt : Yes

Product Code : PTL, DTL, PTM

Prescription Use : Yes

Device Count : 1

Angioway - 06936733735961 Catalog Number :

Device Description : Inflation Device Kits is indicated for use in percutaneous coronary Intervention

Device Class : 2

Duns Number: 529853921

Premarket Exempt : Yes

Product Code : PTL, DTL, PTM

Prescription Use : Yes

Device Count : 1

Angioway - 06936733735978 Catalog Number :

Device Description : Inflation Device Kits is indicated for use in percutaneous coronary Intervention

Device Class : 2

Duns Number: 529853921

Premarket Exempt : Yes

Product Code : PTM, DTL, PTL

Prescription Use : Yes

Device Count : 1

Angioway - 06936733735985 Catalog Number :

Device Description : Inflation Device Kits is indicated for use in percutaneous coronary Intervention

Device Class : 2

Duns Number: 529853921

Premarket Exempt : Yes

Product Code : DTL, PTM

Prescription Use : Yes

Device Count : 1

Angioway - 06936733735992 Catalog Number :

Device Description : Inflation Device Kits is indicated for use in percutaneous coronary Intervention

Device Class : 2

Duns Number: 529853921

Premarket Exempt : Yes

Product Code : PTM, DTL

Prescription Use : Yes

Device Count : 1

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