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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

BRUXI+, single — Class I MDR by Dr. Hinz Dental-Vertrieb…

MD Atlas
Dr. Hinz Dental-Vertriebsgesellschaft mbH & Co. KG

EUDAMED last updated this device on Jan 31, 2024

BRUXI+, single

4260620320034M

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Dr. Hinz Dental-Vertriebsgesellschaft mbH & Co. KG
UDI-DI code: 04260620320674
Reference / catalog number: 93800

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Manufacturer information

Organization name: Dr. Hinz Dental-Vertriebsgesellschaft mbH & Co. KG
SRN: DE-MF-000006965
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: BRUXI+, single
UDI-DI code: 04260620320674
Basic UDI-DI: 4260620320034M
Reference / catalog number: 93800
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: BRUXI+ prevents nocturnal teeth grinding, relaxes the chewing muscles and protects tooth enamel. Nocturnal teeth grinding is widespread: about 20% of all children and adolescents are affected. Noisy teeth grinding can occur as early as after the eruption of the deciduous molars in the 2nd year of life. Applied at an early stage - from the age of 3 - grinding can be permanently eliminated. Individualization in the mouth directly with DIRECT for BRUXI+ and SILCOfix bonding agent is necessary (not included in delivery). Incl. storage box and user manual
Additional information URL: https://www.dr-hinz-dental.de/shop/de/bruxi-einzeln-93800
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q010499ORTHODONTIC DEVICES - 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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