PRODUCT FOR HEMOSTASIS ASSESSMENT - ANVISA Registration 80003610553
Access comprehensive regulatory information for PRODUCT FOR HEMOSTASIS ASSESSMENT in Brazil's medical device market through Pure Global AI's free database. This Risk Class II medical device is registered under ANVISA number 80003610553 and manufactured by TEM INNOVATIONS GMBH. The registration is held by WERFEN MEDICAL LTDA with validity until currently active (VIGENTE).
This page provides complete technical specifications for this device, regulatory compliance details, 5 similar products found using AI-powered semantic search, 5 companies making the same product including MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD., TEM INNOVATIONS GMBH, and 5 recent registrations in the same technical category. Pure Global AI offers free access to over 100,000+ Brazilian medical device registrations, helping global MedTech companies navigate ANVISA regulations, identify competitors, and discover partnership opportunities efficiently.

Janaina dos Santos de Miranda
🇧🇷 Brazil Regulatory Expert
Need help with your Brazil registration?
Contact Pure Global Brazil TeamDevice Details
Registration Details
80003610553
25351367619201769
02004662000165
Company Information
Dates and Status
Feb 14, 2018
VIGENTE
09/18/2025 19:00:01
PRODUCT FOR HEMOSTASIS ASSESSMENT
ROTEM sigma complete
TEM INNOVATIONS GMBH
80003610538
Nov 27, 2017
REAGENT / SYSTEM FOR PLATELET AGGREGATION
ROTEM sigma completo + hep
TEM INNOVATIONS GMBH
80291330029
Nov 20, 2017
REAGENT / SYSTEM FOR PLATELET AGGREGATION
ROTEM sigma completo
TEM INNOVATIONS GMBH
80291330030
Nov 20, 2017
Instrument for hemostasis
ROTEM sigma
TEM INNOVATIONS GMBH
80291330027
Feb 20, 2017
Instrument for hemostasis
ROTEM® sigma
TEM INNOVATIONS GMBH
80003610528
Aug 07, 2017
PRODUTO PARA AVALIAÇÃO DA HEMOSTASIA
FAMILIA STA® RIVAROXABAN
DIAGNOSTICA STAGO S.A.S
81457600071
Mar 05, 2025
PRODUTO PARA AVALIAÇÃO DA HEMOSTASIA
Familia TEG® 6s - Citrated: K, KH, RT, FF
HAEMONETICS S.A.
80102513345
Jan 13, 2025
PRODUTO PARA AVALIAÇÃO DA HEMOSTASIA
TEG® 6s - PlateletMapping® ADP & AA
HAEMONETICS S.A.
80102513295
Sep 02, 2024
PRODUTO PARA AVALIAÇÃO DA HEMOSTASIA
TEG® 6s - PlateletMapping® ADP
HAEMONETICS S.A.
80102513296
Sep 02, 2024
PRODUTO PARA AVALIAÇÃO DA HEMOSTASIA
Reagente de Ativação de Kaolin
MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
82120390001
Feb 05, 2024