Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

GAMMA Dental Software®, "AM"… — Class IIa MDR

MD Atlas
"Gamma" Medizinisch-wissenschaftliche Fortbildungs GmbH

EUDAMED last updated this device on Feb 20, 2025

GAMMA Dental Software®, "AM" Version 8.8

912012191GDSW1Z2

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: "Gamma" Medizinisch-wissenschaftliche Fortbildungs GmbH
UDI-DI code: 09120121910222
Reference / catalog number: 03-GDSWAM

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Related devices

08-00G200912012191CADIAXSWOn the market 08-SP0250912012191CADIAXSWOn the market 01-10D200-2912012191CADIAXSWOn the market 01-SP0065912012191CADIAXSWOn the market 07-10D200-2912012191CADIAXSWOn the market

Market distribution

Primary placement in Austria; available across 1 country total.

Country	On market since	Until
AustriaPrimary placement		Still on market

Device identification

Trade name: GAMMA Dental Software®, "AM" Version 8.8
UDI-DI code: 09120121910222
Basic UDI-DI: 912012191GDSW1Z2
Reference / catalog number: 03-GDSWAM
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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

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.