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Regulatory Documents


Nissha Medical Technologies

Graphic Controls | Nissha Medical Technologies

GLOBAL HEADQUARTERS
400 Exchange Street
Buffalo, NY 14204

P: 800.669.6905


<p>EU MDR 2017/745</p>

EU MDR 2017/745


Valid Through:
29/12/2028


<p>EN ISO 13485:2016</p>

EN ISO 13485:2016


Valid Through:
29/12/2024


<p>ISO 13485:2016</p>

ISO 13485:2016


Valid Through:
29/12/2024


<p>UKCA Certificate</p>

UKCA Certificate


Valid Through:
29/12/2028


<p>UK MDR - Decision Report</p>

UK MDR - Decision Report


Valid Through:
29/12/2028


Nissha Medical Technologies

United Kingdom

EUROPEAN HEADQUARTERS
Torbay Business Park
Woodview Road
Paignton, Devon
TQ4 7HP
United Kingdom

P: +44 1803 860100
F: +44 1803 863838
E: [email protected]


<p>ISO 13485:2016<br />EN ISO 13485:2016</p>

ISO 13485:2016
EN ISO 13485:2016


Valid Through:
29/03/2026


<p>MDSAP 707430</p>

MDSAP 707430


Valid Through:
29/03/2026


<p>93/42/EEC on Medical Devices Annex II</p>

93/42/EEC on Medical Devices Annex II


Valid Through:
26/05/2024


<p>UKCA</p>

UKCA


Valid Through:
05/04/2025


Nissha Medical Technologies SAS

France

Nissha Medical Technologies SAS
23-25 Boulevard de la Paix
95800 Cergy
France

P: +33 1 39 72 66 66
F: +33 1 39 72 61 61


<p>EN ISO 13485:2016</p>

EN ISO 13485:2016


Valid Through:
26/12/2026


<p>ISO 13485:2016 MDSAP</p>

ISO 13485:2016 MDSAP


Valid Through:
26/12/2026


Biomedical Innovations

Colorado Springs Innovation Center

CEA Medical Manufacturing
1735 Merchants Court
Colorado Springs, Colorado 80916

P: 719.591.5300
F: 716.591.5304


<p>ISO 13485:2016</p>

ISO 13485:2016


Valid Through:
28/11/2025

 

Vermed
Austria

Tyrolmed GmbH
Egger-Lienz-Str. 1d
6020 Innsbruck
Austria

P: +43 512 94034
F: +43 512 94034-2
E: [email protected]


<p>ISO 13485:2016</p>

ISO 13485:2016


Valid Through:
22/03/2025


Biomedical Innovations

Wolcott Connecticut - Innovation Center

Sequel Specialty Products
1  Hillside Drive
Wolcott, CT 06716

P: 203.759.1020


<p>ISO 13485:2016</p>

ISO 13485:2016


Valid Through:
10/08/2026


<p>EN ISO 13485:2016</p>

EN ISO 13485:2016


Valid Through:
16/08/2026


Biomedical Innovations

Dominican Republic

CEA Global Dominicana
Zona Franca Industrial
San Pedro de Marcoris
Dominican Republic


<p>ISO 13485:2016</p>

ISO 13485:2016


Valid Through:
20/02/2026


Biomedical Innovations

Sandpoint - Innovation Center

LeadLok
814 Airport Way
Sandpoint, ID 83864

P: 800.201.3958
E: [email protected]


<p>ISO 13485:2016</p>

ISO 13485:2016


Valid Through:
20/04/2026