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Cochlear® Nucleus® 7 S Processing Unit (Sand, CP1002)

CP1002

Class IIIMDR 2017/745On the marketActive device

Manufacturer: Cochlear Limited
Manufacturer SRN: AU-MF-000009890
UDI-DI: 09321502052191
Basic UDI-DI: 9321502CP1002BW
Reference: P1712548
EMDN: J0380
EMDN description: AUDITORY ACTIVE-IMPLANTABLE DEVICES - ACCESSORIES
First on market country: Germany
Safety summary (SSCP/SSP): D2232215 · Rev. Rev. 3
Authorised representative: Cochlear Deutschland GmbH & Co. KG
Last updated: 10.08.2026 16:22

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Cochlear® Nucleus® 7 SE Processing Unit (Sand, CP1001)

CP1001

Class IIIMDR 2017/745On the marketActive device

Manufacturer: Cochlear Limited
Manufacturer SRN: AU-MF-000009890
UDI-DI: 09321502052146
Basic UDI-DI: 9321502CP1001BU
Reference: P1711906
EMDN: J0380
EMDN description: AUDITORY ACTIVE-IMPLANTABLE DEVICES - ACCESSORIES
First on market country: Germany
Safety summary (SSCP/SSP): D2234175 · Rev. Rev. 3
Authorised representative: Cochlear Deutschland GmbH & Co. KG
Last updated: 10.08.2026 16:22

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Cochlear® Nucleus® 7 SE Processing Unit (Black, CP1001)

Class IIIMDR 2017/745On the marketActive device

Manufacturer: Cochlear Limited
Manufacturer SRN: AU-MF-000009890
UDI-DI: 09321502052153
Basic UDI-DI: 9321502CP1001BU
Reference: P1711905
EMDN: J0380
EMDN description: AUDITORY ACTIVE-IMPLANTABLE DEVICES - ACCESSORIES
First on market country: -
Safety summary (SSCP/SSP): D2234175 · Rev. Rev. 3
Authorised representative: Cochlear Deutschland GmbH & Co. KG
Last updated: 10.08.2026 16:21

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Cochlear® Nucleus® 7 SE Processing Unit (Brown, CP1001)

Class IIIMDR 2017/745On the marketActive device

Manufacturer: Cochlear Limited
Manufacturer SRN: AU-MF-000009890
UDI-DI: 09321502052160
Basic UDI-DI: 9321502CP1001BU
Reference: P1711903
EMDN: J0380
EMDN description: AUDITORY ACTIVE-IMPLANTABLE DEVICES - ACCESSORIES
First on market country: -
Safety summary (SSCP/SSP): D2234175 · Rev. Rev. 3
Authorised representative: Cochlear Deutschland GmbH & Co. KG
Last updated: 10.08.2026 16:21

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Cochlear® Nucleus® 7 SE Processing Unit (Grey, CP1001)

Class IIIMDR 2017/745On the marketActive device

Manufacturer: Cochlear Limited
Manufacturer SRN: AU-MF-000009890
UDI-DI: 09321502052177
Basic UDI-DI: 9321502CP1001BU
Reference: P1711902
EMDN: J0380
EMDN description: AUDITORY ACTIVE-IMPLANTABLE DEVICES - ACCESSORIES
First on market country: -
Safety summary (SSCP/SSP): D2234175 · Rev. Rev. 3
Authorised representative: Cochlear Deutschland GmbH & Co. KG
Last updated: 10.08.2026 16:21

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Cochlear® Nucleus® 7 SE Processing Unit (White, CP1001)

Class IIIMDR 2017/745On the marketActive device

Manufacturer: Cochlear Limited
Manufacturer SRN: AU-MF-000009890
UDI-DI: 09321502052184
Basic UDI-DI: 9321502CP1001BU
Reference: P1711900
EMDN: J0380
EMDN description: AUDITORY ACTIVE-IMPLANTABLE DEVICES - ACCESSORIES
First on market country: -
Safety summary (SSCP/SSP): D2234175 · Rev. Rev. 3
Authorised representative: Cochlear Deutschland GmbH & Co. KG
Last updated: 10.08.2026 16:21

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Cochlear® Nucleus® 7 S Processing Unit (Black, CP1002)

Class IIIMDR 2017/745On the marketActive device

Manufacturer: Cochlear Limited
Manufacturer SRN: AU-MF-000009890
UDI-DI: 09321502052207
Basic UDI-DI: 9321502CP1002BW
Reference: P1712529
EMDN: J0380
EMDN description: AUDITORY ACTIVE-IMPLANTABLE DEVICES - ACCESSORIES
First on market country: -
Safety summary (SSCP/SSP): D2232215 · Rev. Rev. 3
Authorised representative: Cochlear Deutschland GmbH & Co. KG
Last updated: 10.08.2026 16:21

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Cochlear® Nucleus® 7 S Processing Unit (Brown, CP1002)

Class IIIMDR 2017/745On the marketActive device

Manufacturer: Cochlear Limited
Manufacturer SRN: AU-MF-000009890
UDI-DI: 09321502052214
Basic UDI-DI: 9321502CP1002BW
Reference: P1712544
EMDN: J0380
EMDN description: AUDITORY ACTIVE-IMPLANTABLE DEVICES - ACCESSORIES
First on market country: -
Safety summary (SSCP/SSP): D2232215 · Rev. Rev. 3
Authorised representative: Cochlear Deutschland GmbH & Co. KG
Last updated: 10.08.2026 16:21

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Cochlear® Battery Cover (Sand, BC2)

Class IIIMDR 2017/745On the market

Manufacturer: Cochlear Limited
Manufacturer SRN: AU-MF-000009890
UDI-DI: 09321502054577
Basic UDI-DI: 9321502CP1001_2BatCoverEN
Reference: P1713402
EMDN: J0380
EMDN description: AUDITORY ACTIVE-IMPLANTABLE DEVICES - ACCESSORIES
First on market country: -
Safety summary (SSCP/SSP): D2234175 · Rev. Rev. 3
Authorised representative: Cochlear Deutschland GmbH & Co. KG
Last updated: 10.08.2026 16:21

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Cochlear® Battery Cover (White, BC2)

Class IIIMDR 2017/745On the market

Manufacturer: Cochlear Limited
Manufacturer SRN: AU-MF-000009890
UDI-DI: 09321502054591
Basic UDI-DI: 9321502CP1001BatCoverJU
Reference: P1713404
EMDN: J0380
EMDN description: AUDITORY ACTIVE-IMPLANTABLE DEVICES - ACCESSORIES
First on market country: -
Safety summary (SSCP/SSP): D2234175 · Rev. Rev. 3
Authorised representative: Cochlear Deutschland GmbH & Co. KG
Last updated: 10.08.2026 16:21

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Cochlear® Battery Cover (Black, BC2)

Class IIIMDR 2017/745On the market

Manufacturer: Cochlear Limited
Manufacturer SRN: AU-MF-000009890
UDI-DI: 09321502054607
Basic UDI-DI: 9321502CP1001_2BatCoverEN
Reference: P1713400
EMDN: J0380
EMDN description: AUDITORY ACTIVE-IMPLANTABLE DEVICES - ACCESSORIES
First on market country: -
Safety summary (SSCP/SSP): D2234175 · Rev. Rev. 3
Authorised representative: Cochlear Deutschland GmbH & Co. KG
Last updated: 10.08.2026 16:21

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Cochlear® Standard Rechargeable Battery Module (Grey, SR2)

Class IIIMDR 2017/745On the marketActive device

Manufacturer: Cochlear Limited
Manufacturer SRN: AU-MF-000009890
UDI-DI: 09321502054621
Basic UDI-DI: 9321502CP1001RechBatPS
Reference: P1724423
EMDN: J0380
EMDN description: AUDITORY ACTIVE-IMPLANTABLE DEVICES - ACCESSORIES
First on market country: -
Safety summary (SSCP/SSP): D2234175 · Rev. Rev. 3
Authorised representative: Cochlear Deutschland GmbH & Co. KG
Last updated: 10.08.2026 16:21

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Cochlear® Osia® Smart App (iOS, v1.2)

Class IIIMDR 2017/745On the marketActive device

Manufacturer: Cochlear Limited
Manufacturer SRN: AU-MF-000009890
UDI-DI: 09321502083577
Basic UDI-DI: 9321502OsiaSmartAppDQ
Reference: P1340352
EMDN: J0380
EMDN description: AUDITORY ACTIVE-IMPLANTABLE DEVICES - ACCESSORIES
First on market country: -
Safety summary (SSCP/SSP): D2217341 · Rev. v3
Authorised representative: Cochlear Deutschland GmbH & Co. KG
Last updated: 10.08.2026 16:21

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Belt, Curved, Extended

Axonics Sacral Neuromodulation System

Class IIIMDR 2017/745On the marketActive deviceImplantable

Manufacturer: Axonics Inc.
Manufacturer SRN: US-MF-000008413
UDI-DI: 10810005340431
Basic UDI-DI: 081000534AXNXZ8
Reference: 9108-E
EMDN: J020480
EMDN description: SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES
First on market country: Netherlands
Safety summary (SSCP/SSP): 110-0421 · Rev. C
Authorised representative: Emergo Europe B.V.
Last updated: 08.08.2026 07:25

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Belt, Curved, Regular

Axonics Sacral Neuromodulation System

Class IIIMDR 2017/745On the marketActive deviceImplantable

Manufacturer: Axonics Inc.
Manufacturer SRN: US-MF-000008413
UDI-DI: 10810005340424
Basic UDI-DI: 081000534AXNXZ8
Reference: 9108-R
EMDN: J020480
EMDN description: SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES
First on market country: Netherlands
Safety summary (SSCP/SSP): 110-0421 · Rev. C
Authorised representative: Emergo Europe B.V.
Last updated: 08.08.2026 07:21

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Axonics Charging System

1401

AIMDD scopeAIMDDOn the marketActive device

Manufacturer: Axonics Inc.
Manufacturer SRN: US-MF-000008413
UDI-DI: 10810005340011
Basic UDI-DI: B-10810005340011
Reference: 1401
EMDN: J020480
EMDN description: SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 08.08.2026 07:16

Manufacturer products Authorised representative products Authorised representative actors View details

Clinician Programmer

2501

Class IIIAIMDDOn the marketActive device

Manufacturer: Axonics Inc.
Manufacturer SRN: US-MF-000008413
UDI-DI: 10810005340035
Basic UDI-DI: 081000534AXNXZ8
Reference: 2501
EMDN: J020480
EMDN description: SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 08.08.2026 07:16

Manufacturer products Authorised representative products Authorised representative actors View details

Trial Stimulator

1601

Class IIIAIMDDOn the marketActive deviceSingle use

Manufacturer: Axonics Inc.
Manufacturer SRN: US-MF-000008413
UDI-DI: 10810005340059
Basic UDI-DI: 081000534AXNXZ8
Reference: 1601
EMDN: J020480
EMDN description: SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 08.08.2026 07:16

Manufacturer products Authorised representative products Authorised representative actors View details

Lead Implant Kit

1801

Class IIIAIMDDOn the marketSingle useSterile

Manufacturer: Axonics Inc.
Manufacturer SRN: US-MF-000008413
UDI-DI: 10810005340080
Basic UDI-DI: 081000534AXNXZ8
Reference: 1801
EMDN: J020480
EMDN description: SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 08.08.2026 07:16

Manufacturer products Authorised representative products Authorised representative actors View details

Axonics Remote Control

2301

AIMDD scopeAIMDDOn the marketActive device

Manufacturer: Axonics Inc.
Manufacturer SRN: US-MF-000008413
UDI-DI: 10810005340103
Basic UDI-DI: B-10810005340103
Reference: 2301
EMDN: J020480
EMDN description: SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 08.08.2026 07:16

Manufacturer products Authorised representative products Authorised representative actors View details