Homologation d`un instrument médical Medical Device Licence

Transcription

Santé Health
Canada Canada
LN/NH:
Therapeutic Products Directorate
Medical Devices Bureau
Direction des produits thérapeutiques
Bureau des matériels médicaux
92421
Medical Device Licence
Homologation d'un instrument médical
Licence Number:
92421
No d'homologation:
First Issue Date:
2013/12/10
Première date de délivrance:
Device Class/Classe de l'instrument: 2
La présente homologation est délivrée en vertu
de l'article 36 du Règlement sur les instruments
médicaux pour l'instrument médical suivant:
This Licence is issued in accordance with the
Medical Devices Regulations, Section 36,
for the following medical device:
Licence Name/Nom de l'homologation:
URINE DRUG TEST / DIP CARDS
Licence Type/Type d'homologation:
Family / Famille
Manufacturer Name & Address/Nom du fabricant & adresse
AMERICAN SCREENING CORP.
7607 FERN AVE.
SUITE 703
SHREVEPORT, LOUISIANA
UNITED STATES
71105
Cindy Evans, A/Director, Medical Devices Bureau/Directeur, Bureau des matériels médicaux
_________________________________________________________
Application Number:
Numéro de la demande:
218670
Manufacturer ID:
Identificateur du fabricant:
135101
Santé Health
Canada Canada
LN/NH:
92421
Components/Parts/Accessories/Devices for this Licence
Les composantes, parties, accessoires et instruments médicaux pour cette homologation
ONESCREEN
Device ID/No de l'instrument: 596559
Device Identifier / Identificateur de l'instrument
(Model/Catalog Detail/No de modèle/Catalogue):
ASC-DAM-114
ASC-DBA-114
ASC-DBU-114
ASC-DBZ-114
ASC-DCO-114
ASC-DMA-114
ASC-DMD-114
ASC-DMO-114
ASC-DMT-114
ASC-DOA-10104
ASC-DOA-1104
ASC-DOA-124
ASC-DOA-134
ASC-DOA-1364
ASC-DOA-144
ASC-DOA-1464
ASC-DOA-154
ASC-DOA-1554
ASC-DOA-164
ASC-DOA-164-341
ASC-DOA-164-551
ASC-DOA-1654
ASC-DOA-174
ASC-DOA-184
ASC-DOA-1854
ASC-DOA-194
ASC-DOA-1954
ASC-DOA-2054
ASC-DOA-2104
ASC-DOA-2114
ASC-DOA-2154
ASC-DOA-2254
Application Number:
218670
Page 2
Manufacturer ID:
135101
Santé Health
Canada Canada
LN/NH:
92421
ASC-DOA-234
ASC-DOA-254
ASC-DOA-264
ASC-DOA-274
ASC-DOA-3104
ASC-DOA-3114
ASC-DOA-3124
ASC-DOA-334
ASC-DOA-354
ASC-DOA-424
ASC-DOA-434
ASC-DOA-454
ASC-DOA-5104
ASC-DOA-5124
ASC-DOA-524
ASC-DOA-544
ASC-DOA-5446
ASC-DOA-594
ASC-DOA-644
ASC-DOA-654
ASC-DOA-664
ASC-DOA-7104
ASC-DOA-744
ASC-DOA-754
ASC-DOA-8104
ASC-DOA-8124
ASC-DUD-11104
ASC-DUD-154-201
ASC-DUD-1554-201
ASC-DUD-454-201
ASC-DUD-9104
ASC-DUD1104051
ASCDOA1124011T
ASCDUD-164-141
DISCOVER TEST CARD
Device ID/No de l'instrument: 596560
Device Identifier / Identificateur de l'instrument
(Model/Catalog Detail/No de modèle/Catalogue):
DIS-DAM-114
Application Number:
218670
Page 3
Manufacturer ID:
135101
Santé Health
Canada Canada
LN/NH:
92421
DIS-DBA-114
DIS-DBU-114
DIS-DBZ-114
DIS-DCO-114
DIS-DMA-114
DIS-DMD-114
DIS-DMO-114
DIS-DMT-114
DIS-DOA-1104
DIS-DOA-1124
DIS-DOA-124
DIS-DOA-134
DIS-DOA-144
DIS-DOA-154
DIS-DOA-164
DIS-DOA-174
DIS-DOA-184
DIS-DOA-194
DIS-DOA-2114
DIS-DOA-234
DIS-DOA-254
DIS-DOA-255
DIS-DOA-264
DIS-DOA-274
DIS-DOA-295
DIS-DOA-3104
DIS-DOA-3124
DIS-DOA-334
DIS-DOA-354
DIS-DOA-394
DIS-DOA-4104
DIS-DOA-424
DIS-DOA-5104
DIS-DOA-524
DIS-DOA-554
DIS-DOA-564
DIS-DOA-6104
DIS-DOA-6124
DIS-DOA-654
DIS-DOA-655
DIS-DOA-664
Application Number:
218670
Page 4
Manufacturer ID:
135101
Santé Health
Canada Canada
LN/NH:
92421
DIS-DOA-7104
DIS-DOA-754
DIS-DOA-865
DIS-DOP-114
DIS-DOX-114
DIS-DPC-114
DIS-DPP-114
DIS-DTC-114
DIS-DTH-114
Application Number:
218670
Page 5
Manufacturer ID:
135101

Homologation d`un instrument médical Medical Device Licence

Transcription

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