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Dialysis Machine - India CDSCO Medical Device Registration

Dialysis Machine is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000271_e739e8ea38f60784ced96e1718055837_289638fc351217e9b01f334d44d59bc7. This device is marketed under the brand name Dialog+ Single Pump, Dialog+ double-pump, Dialog+ HDF-online. The license holder is B BRAUN MEDICAL INDIA PRIVATE LIMITED ,OFFICE NO. A/11, GRD FLR, GUNDECHA ONCLAVE PREMISES CHSL, A WING, CTS NO. 99A & 97A, SAKI VILLAGE, KHERANI RD, SAKINAKA, MUMBAI, Tal - SAKINAKA ( MUMBAI-ZONE4 ) ,Mumbai Suburban Maharashtra ,400072 ,India, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered
Class Class C
Dialysis Machine
UID: IMP/MD/2021/000271_e739e8ea38f60784ced96e1718055837_289638fc351217e9b01f334d44d59bc7

Brand Name

Dialog+ Single Pump, Dialog+ double-pump, Dialog+ HDF-online

Device Class

Class C

Approving Authority

CDSCO

Product Information

The dialysis machine can be used for implementing and monitoring haemodialysis treatments for patients with acute or chronic kidney failure. The system can be used for hospital, health centre, limited-care or home dialysis. Depending on the model, the following types of therapy can be carried out with the system: Hemodialysis (Dialog+ Single Pump, Dialog+ double-pump, Dialog+ HDF-online), Isolated ultrafiltration (Dialog+ Single Pump, Dialog+ double-pump, Dialog+ HDF-online): Sequential therapy (Dialog+ Single Pump, Dialog+ double-pump, Dialog+ HDF-online), Hemodiafiltration (Dialog+ Single Pump, Dialog+ double-pump, Dialog+ HDF-online) , Hemofiltration (Dialog+ Single Pump, Dialog+ double-pump, Dialog+ HDF-online)

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