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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

ISTclassic®NEW-Set by Prof. Hinz,… — Class I MDR

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

EUDAMED last updated this device on Jan 31, 2024

ISTclassic®NEW-Set by Prof. Hinz, foils Ø 120 mm

4260620320054R

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: 04260620320834
Reference / catalog number: 980010

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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: ISTclassic®NEW-Set by Prof. Hinz, foils Ø 120 mm
UDI-DI code: 04260620320834
Basic UDI-DI: 4260620320054R
Reference / catalog number: 980010
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: By the changed mounting device within the molar area of the lower jaw and in the canines area of the upper jaw the protrusion of the lower jaw is permanently secured during open mouth posture. The set consists of 1 pair of guiding rods and 4 fixing screws, foils (Ø 120 mm), polymer, monomer, a safety key, a bite fork for the controlled protrusive adjustment of the lower jaw and a storage box for the patient.
Additional information URL: https://www.dr-hinz-dental.de/shop/de/980010?q=980010
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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