EC Declaration of Conformity

Pofam-Poznan
EC Declaration of Conformity
Pofam Poznan Co. Ltd.
Lindego 6
60-573 Poznan
hereby declares that
MAXIMA breast prosthesis
is class 1/other medical device; Rule I
according to provisions of the Directive 93/42/EEC.
The product is CE marked according to this declaration.
Conformity assesment procedure was carried out accoding to Annex VII of the above mentioned
Directive.
Poznan, 06.08.2009
Pofam-Poznan Ltd.
60-573 Poznan, 6 Lindego str., tel. 48 61 845 69 10 (Export Dept.), fax. 48 61 845 69 01
e-mail: office@pofam.poznan.pl; www.pofam.poznan.pl
Czeslaw Formankiewicz
Managing Director
Annex to the Declaration of Conformity dated 06.08.2009
The above mentioned declaration of conformity made out by Pofam-Poznan Co. Ltd. covers the
following MAXIMA breast prothesis:
Reference
4001 / 6/80
4001 / 7/85
4001 / 8/90
4001 / 9/95
4001 / 10/100
4001 / 11/105
4001 / 12/110
4001 / 13/115
4001 / 14/120
9006 / 6/80
9006 / 7/85
9006 / 8/90
9006 / 9/95
9006 / 10/100
9006 / 11/105
9006 / 12/110
9006 / 13/115
9006 / 14/120
Item Number
8291230804007
8291230854002
8291230904004
8291230954009
8291231004000
8291231054005
8291231104007
8291231154002
8291231204004
8291220809005
8291220859000
8291220909002
8291220959007
8291221009008
8291221059003
8291221109005
8291221159000
8291221209002
Description
Breast Prosthesis, Standart
Breast Prosthesis, Standart
Breast Prosthesis, Standart
Breast Prosthesis, Standart
Breast Prosthesis, Standart
Breast Prosthesis, Standart
Breast Prosthesis, Standart
Breast Prosthesis, Standart
Breast Prosthesis, Standart
Breast Prosthesis, Heart
Breast Prosthesis, Heart
Breast Prosthesis, Heart
Breast Prosthesis, Heart
Breast Prosthesis, Heart
Breast Prosthesis, Heart
Breast Prosthesis, Heart
Breast Prosthesis, Heart
Breast Prosthesis, Heart
Poznan, 06.08.2009
Pofam-Poznan Ltd.
60-573 Poznan, 6 Lindego str., tel. 48 61 845 69 10 (Export Dept.), fax. 48 61 845 69 01
e-mail: office@pofam.poznan.pl; www.pofam.poznan.pl
Czeslaw Formankiewicz
Managing Director
Pofam-Poznan
EC Uygunluk Beyanı
Pofam Poznan Co. Ltd.
Lindego 6
60-573 Poznan
İşbu belge ile beyan eder ki;
MAXIMA meme protezleri
93/42/EEC Direktifi koşullarına göre
Sınıf I/Diğer medikal cihazdır; Kural I.
Ürün bu beyana göre CE işaretlidir.
Uygunluk değerlendirme prosedürü yukarıda belirtilen direktif Ek VII’ye göre gerçekleştirilmiştir.
Poznan, 06.08.2009
Pofam-Poznan Ltd.
60-573 Poznan, 6 Lindego str., tel. 48 61 845 69 10 (Export Dept.), fax. 48 61 845 69 01
e-mail: office@pofam.poznan.pl; www.pofam.poznan.pl
Czeslaw Formankiewicz
İdari Müdür
(imza var)
06.08.2009 Tarihli Uygunluk Beyanı’nın Eki
Yukarıda belirtilen uygunluk beyanı Pofam-Poznan Ltd. tarafından hazırlanmıştır ve aşağıdaki
MAXIMA meme protezlerini kapsar:
Referans
4001 / 6/80
4001 / 7/85
4001 / 8/90
4001 / 9/95
4001 / 10/100
4001 / 11/105
4001 / 12/110
4001 / 13/115
4001 / 14/120
9006 / 6/80
9006 / 7/85
9006 / 8/90
9006 / 9/95
9006 / 10/100
9006 / 11/105
9006 / 12/110
9006 / 13/115
9006 / 14/120
Ürün Numarası
8291230804007
8291230854002
8291230904004
8291230954009
8291231004000
8291231054005
8291231104007
8291231154002
8291231204004
8291220809005
8291220859000
8291220909002
8291220959007
8291221009008
8291221059003
8291221109005
8291221159000
8291221209002
Açıklama
Meme Protezi, Standart
Meme Protezi, Standart
Meme Protezi, Standart
Meme Protezi, Standart
Meme Protezi, Standart
Meme Protezi, Standart
Meme Protezi, Standart
Meme Protezi, Standart
Meme Protezi, Standart
Meme Protezi, Kalp
Meme Protezi, Kalp
Meme Protezi, Kalp
Meme Protezi, Kalp
Meme Protezi, Kalp
Meme Protezi, Kalp
Meme Protezi, Kalp
Meme Protezi, Kalp
Meme Protezi, Kalp
Poznan, 06.08.2009
Pofam-Poznan Ltd.
60-573 Poznan, 6 Lindego str., tel. 48 61 845 69 10 (Export Dept.), fax. 48 61 845 69 01
e-mail: office@pofam.poznan.pl; www.pofam.poznan.pl
Czeslaw Formankiewicz
İdari Müdür
(imza var)