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Flowable Gelatin Haemostatic Matrix Kit - India CDSCO Medical Device Registration

Flowable Gelatin Haemostatic Matrix Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2021/000179_a777c29fb6dd824f33299b85325545cb_4a36cb931d0c1860b8fdf635dcfcfa86. This device is marketed under the brand name SURGISPON®, MEDISPONGE, UNISPONGE, BLOXANG, GEL-SPONGE, HEMOGEL, HEMOSPONGE, PERISPONGE™, SURGIGEL, TOP DENT DENTOSTAN, EVOSPON, CLINIX, HYGITECH, R&S, KENTDENTAL, OCTOCALOGEN, TOPISPON, SURGISENZ, MVG, SCHMIDT, ILION DENTAL, GELASPON, GELASPON KDM, PROCLINIC, BESTDENT, STELLIGEL, BIOSPONGE, FLOSPONG, SMI-SPON, MEDISPON, CLINISPON, I-SPONGE, MERIFEIM, DSI SPONGE, CHIRUSPONGE, MERIFOAM, IDSPONGE, DENTOSPON, KARESPON, HEMOSPON, ALPHA-SPON. The license holder is M/s ELECTRO MAGNETIC INDUSTRIES, and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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Class Class D
Flowable Gelatin Haemostatic Matrix Kit
UID: MFG/MD/2021/000179_a777c29fb6dd824f33299b85325545cb_4a36cb931d0c1860b8fdf635dcfcfa86

Brand Name

SURGISPON®, MEDISPONGE, UNISPONGE, BLOXANG, GEL-SPONGE, HEMOGEL, HEMOSPONGE, PERISPONGE™, SURGIGEL, TOP DENT DENTOSTAN, EVOSPON, CLINIX, HYGITECH, R&S, KENTDENTAL, OCTOCALOGEN, TOPISPON, SURGISENZ, MVG, SCHMIDT, ILION DENTAL, GELASPON, GELASPON KDM, PROCLINIC, BESTDENT, STELLIGEL, BIOSPONGE, FLOSPONG, SMI-SPON, MEDISPON, CLINISPON, I-SPONGE, MERIFEIM, DSI SPONGE, CHIRUSPONGE, MERIFOAM, IDSPONGE, DENTOSPON, KARESPON, HEMOSPON, ALPHA-SPON

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

Flowable Gelatin Haemostatic Matrix, is indicated in surgical procedures (SURGISPON®, MEDISPONGE, UNISPONGE, BLOXANG, GEL-SPONGE, HEMOGEL, HEMOSPONGE, PERISPONGE™, SURGIGEL, TOP DENT DENTOSTAN, EVOSPON, CLINIX, HYGITECH, R&S, KENTDENTAL, OCTOCALOGEN, TOPISPON, SURGISENZ, MVG, SCHMIDT, ILION DENTAL, GELASPON, GELASPON KDM, PROCLINIC, BESTDENT, STELLIGEL, BIOSPONGE, FLOSPONG, SMI-SPON, MEDISPON, CLINISPON, I-SPONGE, MERIFEIM, DSI SPONGE, CHIRUSPONGE, MERIFOAM, IDSPONGE, DENTOSPON, KARESPON, HEMOSPON, ALPHA-SPON) as an adjunct to haemostasis when control of bleeding by ligature or other conventional methods is ineffective or impractical. Although not necessary, Flowable Gelatin Haemostatic Matrix can be used with or without thrombin to achieve haemostasis.

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