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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

01-SP0065 — Class I MDR by "Gamma" Medizinisch-wiss…

MD Atlas
"Gamma" Medizinisch-wissenschaftliche Fortbildungs GmbH

EUDAMED last updated this device on Feb 7, 2023

01-SP0065

912012191CADIAXSW

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: "Gamma" Medizinisch-wissenschaftliche Fortbildungs GmbH
UDI-DI code: 09120121910048
Reference / catalog number: 01-SP0065

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Manufacturer information

Organization name: "Gamma" Medizinisch-wissenschaftliche Fortbildungs GmbH
SRN: AT-MF-000004222
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW018
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Austria; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 09120121910048
Basic UDI-DI: 912012191CADIAXSW
Reference / catalog number: 01-SP0065
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: Das CADIAX-System dient der Aufzeichnung und Darstellung von Scharnierachsbewegungen des menschlichen Unterkiefers, der Umrechnung dieser Bewegungen auf eine durch den Artikulator vorgegebene Interkondylardistanz und der Berechnung von patientengerechten Einstellungen für diesen Artikulator. Die Anwendung erfolgt durch Zahnärzte und Zahntechniker.
Additional information URL: https://www.gammadental.com/de/downloads.html
Clinical sizes: 0.01 MU50
0.1 MU105

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.