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Axonics Inc.

Manufacturer
🇺🇸 United States·24 Basic UDI-DIs·24 Devices·1 Importer·BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., and BSI Group The Netherlands B.V.

Zhejiang Nurotron Biotechnology Co., Ltd.

Manufacturer
🇨🇳 China·60 Basic UDI-DIs·60 Devices·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.

Saluda Medical Pty Ltd

Manufacturer
🇦🇺 Australia·19 Basic UDI-DIs·19 Devices·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.

Atrotech Oy

Manufacturer
🇫🇮 Finland·1 Basic UDI-DI·1 Device·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH

ZOLL Respicardia, Inc.

Manufacturer
🇺🇸 United States·28 Basic UDI-DIs·28 Devices·BSI Group The Netherlands B.V.

Mainstay Medical Limited

Manufacturer
🇮🇪 Ireland·2 Basic UDI-DIs·2 Devices·BSI Group The Netherlands B.V.

TÜV SÜD Product Service GmbH

Notified body
🇩🇪 Germany·628 Manufacturers·12418 Basic UDI-DIs

BSI Group The Netherlands B.V.

Notified body
🇳🇱 Netherlands·376 Manufacturers·26587 Basic UDI-DIs

559663

Certificate
AIMDD Annex II Section 4·ZOLL Respicardia, Inc. ·BSI Group The Netherlands B.V.·28 Basic UDI-DIs

653955

Certificate
AIMDD Annex II Section 4·Saluda Medical Pty Ltd·BSI Group The Netherlands B.V.·15 Basic UDI-DIs

653955

Certificate
AIMDD Annex II Section 4·Saluda Medical Pty Ltd·BSI Group The Netherlands B.V.·4 Basic UDI-DIs

634655

Certificate
AIMDD Annex II Section 4·Axonics Inc.·BSI Group The Netherlands B.V.·23 Basic UDI-DIs

634655

Certificate
AIMDD Annex II Section 4·Axonics Inc.·BSI Group The Netherlands B.V.·1 Basic UDI-DI

691392

Certificate
AIMDD Annex II Section 4·Zhejiang Nurotron Biotechnology Co., Ltd.·BSI Group The Netherlands B.V.·59 Basic UDI-DIs

Enduro Earhook

Certificate
AIMDD Annex II Section 4·Zhejiang Nurotron Biotechnology Co., Ltd.·BSI Group The Netherlands B.V.·1 Basic UDI-DI

I7 033625 0017

Certificate
AIMDD Annex II Section 4·Atrotech Oy·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

CE576072

Certificate
AIMDD Annex II Section 4·Mainstay Medical Limited·BSI Group The Netherlands B.V.·2 Basic UDI-DIs

Axonics Accessory, Foramen Needle - Long

Device
EU AIMDD · Eu Aimdd Class ·Axonics Inc.·On the market

Axonics Accessory, Foramen Needle - Short

Device
EU AIMDD · Eu Aimdd Class ·Axonics Inc.·On the market

Axonics Trial Stimulator

Device
EU AIMDD · Eu Aimdd Class ·Axonics Inc.·On the market