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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:
12/29/2028


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

EN ISO 13485:2016


Valid Through:
12/29/2024


<p>ISO 13485:2016</p>

ISO 13485:2016


Valid Through:
12/29/2024


<p>UKCA Certificate</p>

UKCA Certificate


Valid Through:
12/29/2028


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

UK MDR - Decision Report


Valid Through:
12/29/2028


Nissha Medical Technologies
Ltd
United Kingdom

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

P: +44 1803 860100
F: +44 1803 863838
E: ukinfo@vermed.com


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

ISO 13485:2016
EN ISO 13485:2016


Valid Through:
3/29/2026


<p>MDSAP 707430</p>

MDSAP 707430


Valid Through:
3/29/2026


<p>UKCA</p>

UKCA


Valid Through:
4/5/2025

 

Nissha Medical Technologies GmbH
Austria

Tyrolmed GmbH
Bundesstraße 25
6063 Rum
Austria

P: +43 512 94034
F: +43 512 94034
E: ATInfo@vermed.com


<p>EC 93/42/EEC</p>

EC 93/42/EEC


Valid Through:
7/25/2023


<p>ISO 13485:2016</p>

ISO 13485:2016


Valid Through:
7/25/2021


<p>ISO 13485:2016 CMDCAS Registration</p>

ISO 13485:2016 CMDCAS Registration


Valid Through:
7/25/2021


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:
12/26/2026


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

ISO 13485:2016 MDSAP


Valid Through:
12/26/2026


Nissha Medical Technologies | Design & Manufacturing

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:
11/28/2025


Nissha Medical Technologies | Design & Manufacturing

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:
8/10/2026


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

EN ISO 13485:2016


Valid Through:
8/16/2026


Nissha Medical Technologies | Design & Manufacturing

Dominican Republic

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


<p>ISO 13485:2016</p>

ISO 13485:2016


Valid Through:
2/20/2026


Nissha Medical Technologies | Design & Manufacturing

Sandpoint - Innovation Center

LeadLok
814 Airport Way
Sandpoint, ID 83864

P: 800.201.3958


<p>ISO 13485:2016</p>

ISO 13485:2016


Valid Through:
4/20/2026