Fatblock (Captoglicolipid). Das Helsinki-Verfahren zu Fatblock® wurde auf Anfrage des türkischen Gesundheitsministeriums eingeleitet. Nun soll geklärt werden, ob es sich bei dem genannten Produkt um e
27.06.2014
Meldung
PD
Product containing Gelatin Tannate
- Background
A product consisting of a gelatin and tannic acid complex was placed on the market as a
medical device. According to the leaflet provided by
31.07.2014
Datei
PD
Version 1
ENQUIRY TO
MEDICAL DEVICE COMPETENT AUTHORITIES
Helsinki Procedure 2013
Problem : Classification of embolization microspheres with the capacity of
lo
31.07.2014
Datei
PD
Version 1
ENQUIRY TO
MEDICAL DEVICE COMPETENT AUTHORITIES
Helsinki Procedure 2013
Confidential between Member States
Problem : Classification of wound gel as Class III Rule 13
Originating
31.07.2014
Datei
PD
ENQUIRY TO
MEDICAL DEVICE COMPETENT AUTHORITIES
Problem : Whether FATBLOCK® Medical Device or Not
Originating CA: Agency for Medicinal Products and Medical Devices of the Ministry of Health
31.07.2014
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page 1 of 46
EUROPEAN COMMISSION
ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL
Consumer Goods
Cosmetics and Medical Devices
MEDDEV. 2.7.1 Rev.3
December 20
31.07.2014
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PD
29 May 2013
German Medicines Manufacturers’ Association
BAH Comments on MEDDEV 2.7/1 Rev. 4
(draft version of 1.5.2013 prepared by the CAMD Clinical TF)
General remarks
BAH welcomes
31.07.2014
Datei
PD
