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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

11.8016 — Class I MDR by Rehadapt GmbH

MD Atlas
Rehadapt GmbH

EUDAMED last updated this device on Mar 18, 2024

11.8016

++B896WheelchairMountsQB

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Rehadapt GmbH
UDI-DI code: +B89611801606
Reference / catalog number: 11.8016

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Manufacturer information

Organization name: Rehadapt GmbH
SRN: DE-MF-000008141
Manufacturer status: Active

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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.

Market distribution

Primary placement in Germany; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: +B89611801606
Basic UDI-DI: ++B896WheelchairMountsQB
Reference / catalog number: 11.8016
Issuing entity: HIBCC

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: M3D mount for the CoMoveIT Smart Head Array. Adds the degrees of freedom needed to compensate for assymetric body posture and allows for quick readjustments for maximum user comfort. Frame clamp not included.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y214299DEVICES FOR INTERPERSONAL COMUNICATION - 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

UDI-PI traceability

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