Sanitary Registration for Platelet Incubators
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ScribdTranslationsSanitary Registration for Platelet Incubators
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ScribdTranslationsRepublic of Colombia
Ministry of Health and Social Protection
National Institute for Drug and Food Monitoring - INVIMA
RESOLUCIÓN No. 2020033241 DE 2 de Octubre de 2020
By which a Sanitary Registration is granted
The Technical Director of Medical Devices and other Technologies of the National Institute of Surveillance
Medications and Foods INVIMA, in exercise of the legal powers conferred in Decree 2078 of 2012,
Regulatory Decree 4725 of 2005, Law 1437 of 2011 and Law 962 of 2005
CONSIDERING
A request for the concession of an automatic sanitary registration has been submitted to this institute.
BASED ON THE VERIFICATION OF THE TECHNICAL LEGAL DOCUMENTATION SUBMITTED TO THE DIRECTORATE
ON MEDICAL DEVICES AND OTHER TECHNOLOGIES, ISSUING A FAVORABLE OPINION FOR THE
ISSUANCE OF THIS SANITARY REGISTRATION.
AS A RESULT OF THE ABOVE, IN ACCORDANCE WITH ARTICLE 57 OF LAW 962 OF 2005 THE
INVIMA will carry out the subsequent control within fifteen (15) days following its
EXPEDITION.
RESOLVE
ARTICLE ONE.- GRANT SANITARY REGISTRATION FOR A TERM OF TEN (10) YEARS TO
PRODUCTO: PLATELET INCUBATORS
BRAND: HELMER INC.
SANITARY REGISTRATION NO.: INVIMA 2020DM-0022156
TYPE OF RECORD: IMPORT AND SELL
HEADLINE(S): HELMER INC WITH DOMICILE IN THE UNITED STATES OF AMERICA
MANUFACTURER(S): HELMER INC WITH DOMICILE IN THE UNITED STATES OF AMERICA
IMPORTADOR(ES): BPL MEDICAL S.A.S WITH ADDRESS IN BOGOTA - D.C.
CONDITIONER(S): BPL MEDICAL S.A.S WITH ADDRESS IN BOGOTA - D.C.
TYPE OF DEVICE BIOMEDICAL SUPPORT TEAM
RISK: IIA
SYSTEMS: ELECTRICS ELECTRONICS ELECTROMECHANICAL
SUBSYSTEMS: PARTS OF THE EQUIPMENT: METAL STRUCTURE WITH TRAYS FOR PLACING
THE PLATES, SLIDING TRAYS AND CONTROL PANEL OF
ON AND OFF, LOW AND HIGH TEMPERATURE ALARMS,
SYSTEM DE REFRIGERATION FOR CONTROL TEMPERATURE
FANS, ELECTRICAL AND ELECTRONIC SYSTEM
USES: STORE THE PLATES AND CONTROL THEIR INCUBATION AND
TEMPERATURE
COMMERCIAL PRESENTATION: UNIT
OBSERVATIONS: THE PRESENT SANITARY REGISTER COVERS THE FOLLOWING MODELS
EXCLUSIVE ACCESSORIES AND SPARE PARTS OF THE EQUIPMENT
Family of the CODE, MODEL OR
DESCRIPCIÓN
REFERENCE REFERENCE
PC100-PRO, PC900-PRO TEAM FOR
INCUBATORS OF ["PC1200-PRO, PC2200H,"] STORAGE AND
PLATELETS PC2200I, PC3200H, PC3200I INCUBATION OF
PC4200H, PC4200I PLATELETS
LIFESPAN: 10 YEARS
FILE NO.: 20189352
RADICACIÓN NO.: 20201176664
DATE OF FILING: 29 09 2020
SECOND ARTICLE.- ONLY THE APPEAL OF
REPLACEMENT, WHICH MUST BE SUBMITTED TO THE DIRECTORATE OF MEDICAL DEVICES AND OTHERS
TECHNOLOGIES, WITHIN TEN (10) DAYS FOLLOWING YOUR NOTIFICATION, UNDER THE TERMS
MENTIONED IN THE CODE OF ADMINISTRATIVE PROCEDURE AND CONTROVERSY
ADMINISTRATIVE.
Republic of Colombia
Ministry of Health and Social Protection
National Institute for Drug and Food Surveillance - INVIMA
RESOLUCIÓN No. 2020033241 DE 2 de Octubre de 2020
By which a Sanitary Registration is granted
The Technical Director of Medical Devices and other Technologies of the National Institute of Surveillance
Medications and Foods INVIMA, in exercise of the legal powers conferred by Decree 2078 of 2012,
Regulatory Decree 4725 of 2005, Law 1437 of 2011, and Law 962 of 2005
ARTICLE THREE.- THIS RESOLUTION TAKES EFFECT FROM THE DATE OF ITS ISSUANCE.
ARTICLE FOUR - THE RIGHTS DERIVED FROM THIS RESOLUTION SHALL BE SUBJECT TO
POSTERIOR CONTROL THAT MUST BE CARRIED OUT BY THE NATIONAL INSTITUTE OF MEDICINE SURVEILLANCE AND
FOODS INVIMA IN ACCORDANCE WITH THE PROVISIONS OF ARTICLE 22 OF DECREE 4725 OF
2005.
Communicate, notify and comply
GIVEN IN BOGOTÁ D.C. ON THE 2ND OF OCTOBER 2020
THIS SPACE, UNTIL SIGNATURE, IS CONSIDERED BLANK.
LUCIA AYALA RODRIGUEZ
TECHNICAL DIRECTOR OF MEDICAL DEVICES AND OTHER TECHNOLOGIES
PROYECTO: LEGAL: FMOSCOSOM, TÉCNICO: JGILV , REVISÓ:CORDINA_VARIOS
