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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

JAC5189 — Class I MDR by Robo Educational Toys…

MD Atlas
Robo Educational Toys B.V.

EUDAMED last updated this device on Jan 7, 2025

JAC5189

++G605JAC5189H6

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Robo Educational Toys B.V.
UDI-DI code: G605JAC5189
Reference / catalog number: JAC5189

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View device family (Basic UDI)

Manufacturer information

Organization name: Robo Educational Toys B.V.
SRN: NL-MF-000039458
Manufacturer status: Active

Related devices

TIME TIMER++G605JAC5106G8On the market TIME TIMER++G605JAC5105G6On the market Time Timer Large++G605JAC5109GEOn the market Time Timer MAX++G605JAC5100FUOn the market Time Timer Medium++G605JAC5108GCOn the market

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.

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Netherlands; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: G605JAC5189
Basic UDI-DI: ++G605JAC5189H6
Reference / catalog number: JAC5189
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: Time Timer Braille is a visual timer created for low vision people.
Additional information URL: https://www.timetimer.eu/
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

G605JAC5189

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

EMDN nomenclature code(s)

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

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - 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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