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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

Grip for iSwitch -Black left — Class I MDR by Ergo Contech

MD Atlas
Ergo Contech

EUDAMED last updated this device on Jul 29, 2022

Grip for iSwitch -Black left

90056600005LU

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Ergo Contech
UDI-DI code: 09005660000057
Reference / catalog number: 5

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View device family (Basic UDI)

Manufacturer information

Organization name: Ergo Contech
SRN: NO-MF-000002649
Manufacturer status: Active

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Arm mounting plate for iSwitch90056600002LNOn the market Arm mounting plate for Smoothie 75 / it-Switch 75 / Simplyworks 7590056600003LQOn the market Grip for iSwitch -Black right90056600004LSOn the market Grip for Small switches -Black left90056600009M4On the market Grip for Small switches -Black right90056600008M2On the market

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Norway; available across 1 country total.

Placed on the market in Norway; per-country availability dates not published.

Device identification

Trade name: Grip for iSwitch -Black left
UDI-DI code: 09005660000057
Basic UDI-DI: 90056600005LU
Reference / catalog number: 5
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Grip is a switch-bracket with wrist-support. It is used to secure a switch in a steady position. The intended user is a person who has been unable to use assistive switches with traditional mounting solutions. The wrist-support is made to be used by most people over the age of 9.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)09005660000057

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Y240999CONTROL DEVICES AND SYSTEMS - OTHER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.