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Organization name
UDI-DI code
Reference / catalog number

STOPPI® pacifier — Class I MDR by Dr. Hinz Dental-Vertrieb…

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

EUDAMED last updated this device on Jan 30, 2024

STOPPI® pacifier

4260620320014H

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: 04260620321350
Reference / catalog number: 90500

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Manufacturer information

Organization name: Dr. Hinz Dental-Vertriebsgesellschaft mbH & Co. KG
SRN: DE-MF-000006965
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: STOPPI® pacifier
UDI-DI code: 04260620321350
Basic UDI-DI: 4260620320014H
Reference / catalog number: 90500
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: STOPPI® is a weaning dummy made of silicon. Two little lateral bite planes for the molars provide the necessary support during the acclimatization phase. If sucking becomes a permanent habit, damaging pacifier, thumb-sucking or baby bottles disrupt the normal development of the jaws. Weaning off sucking at an early stage with the STOPPI® - by the end of the 2nd year of life at the latest - prevents malocclusions and jaw anomalies and can contribute to the self-healing of changes that have already occurred. The STOPPI® is characterized by the fact that there is no foreign body between the incisors so that an open bite is not encouraged and unhindered self-regulation is possible with a slight opening of the bite. The upper and lower jaws can develop normally and the teeth can grow into their correct position. Incl. storage box and user manual
Additional information URL: https://www.dr-hinz-dental.de/shop/de/stoppi-entwoehnungssauger-90500
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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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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.