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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

Rehabilitation Glove — Class I MDR by Cynteract GmbH

MD Atlas
Cynteract GmbH

EUDAMED last updated this device on May 16, 2022

Rehabilitation Glove

42700006066001B8

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Cynteract GmbH
UDI-DI code: 04270000606632
Reference / catalog number: S

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Manufacturer information

Organization name: Cynteract GmbH
SRN: DE-MF-000007727
Manufacturer status: Active

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: Rehabilitation Glove
UDI-DI code: 04270000606632
Basic UDI-DI: 42700006066001B8
Reference / catalog number: S
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: The medical device consists of two parts, the glove and corresponding software. The glove in combination with the software supports the rehabilitation of finger, hand, and arm diseases/injuries in rehabilitation centers and especially at home. Further, the medical device is intended to provide the therapist and attending physician with a summary of the training data. The product is intended for use with an electronic terminal, for example, a smartphone, tablet, or laptop. Games are shown on such a device, which are controlled via the finger/hand/arm movements or forces. In this way, a character can be controlled with the glove in a virtual world.
Additional information URL: https://www.cynteract.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z120602PHYSIOTHERAPY EQUIPMENT

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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

This device is not currently linked to any other device.

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.