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IVD產品CE認證公告機構
National Standards Authority of Ireland (NSAI)
1 Swift Square, Northwood, Santry
Dublin 9
Ireland
0050 Devices for self-testing EC declaration of
conformity
Full quality assurance
system
Production quality
assurance
Annex III
Annex IV
Annex VII
Products referred in Annex II, list A
Products referred in Annex II, list B
Full quality assurance
system
Production quality
assurance
Annex IV
Annex VII
BSI
Kitemark House, Maylands Avenue,
Hemel Hempstead, Hertfordshire HP2 4SQ
United Kingdom
0086 *IVD 0100 - Reagents and reagent products, including
related calibrators and control materials, for determining
the following blood groups
- *IVD 0101 - ABO system
- *IVD 0102 - Rhesus (C, c, D, E, e)
- *IVD 0103 - Anti-Kell
*IVD 0200 - Reagents and reagent products, including
related calibrators and control materials, for the
detection, confirmation and quantification in human
specimens of markers of
- *IVD 0201 - HIV infection (HIV 1 and 2)
- *IVD 0202 - HTLV I and II
- *IVD 0203 - Hepatitis B, C and D
Full quality assurance
system
EC type-examination
Production quality
assurance
Annex IV
Annex V
Annex VII
*IVD 0300 - Reagents, reagent products and devices for
self-diagnosis, including related calibrators and control
materials, for determining, detection, quantification,
diagnosing, evaluating
Full quality assurance
system
EC type-examination
EC verification
Annex IV
Annex V
Annex VI
Annex VII
Creation Date : 21/01/2011
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 98/79/EC In vitro diagnostic medical devices
Name and address of the notified
bodies
ID Responsible for the following products
/Horizontal technical competence
Responsible for the
following procedures
or modules
Annexes or
articles of the
directives
Limitations (English only)
1 / 34
1 Swift Square, Northwood, Santry
Dublin 9
Ireland
0050 Devices for self-testing EC declaration of
conformity
Full quality assurance
system
Production quality
assurance
Annex III
Annex IV
Annex VII
Products referred in Annex II, list A
Products referred in Annex II, list B
Full quality assurance
system
Production quality
assurance
Annex IV
Annex VII
BSI
Kitemark House, Maylands Avenue,
Hemel Hempstead, Hertfordshire HP2 4SQ
United Kingdom
0086 *IVD 0100 - Reagents and reagent products, including
related calibrators and control materials, for determining
the following blood groups
- *IVD 0101 - ABO system
- *IVD 0102 - Rhesus (C, c, D, E, e)
- *IVD 0103 - Anti-Kell
*IVD 0200 - Reagents and reagent products, including
related calibrators and control materials, for the
detection, confirmation and quantification in human
specimens of markers of
- *IVD 0201 - HIV infection (HIV 1 and 2)
- *IVD 0202 - HTLV I and II
- *IVD 0203 - Hepatitis B, C and D
Full quality assurance
system
EC type-examination
Production quality
assurance
Annex IV
Annex V
Annex VII
*IVD 0300 - Reagents, reagent products and devices for
self-diagnosis, including related calibrators and control
materials, for determining, detection, quantification,
diagnosing, evaluating
Full quality assurance
system
EC type-examination
EC verification
Annex IV
Annex V
Annex VI
Annex VII
Creation Date : 21/01/2011
LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 98/79/EC In vitro diagnostic medical devices
Name and address of the notified
bodies
ID Responsible for the following products
/Horizontal technical competence
Responsible for the
following procedures
or modules
Annexes or
articles of the
directives
Limitations (English only)
1 / 34
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