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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

MAPTA — Class IIb MDR by EBG MedAustron GmbH

MD Atlas
EBG MedAustron GmbH

EUDAMED last updated this device on Jun 2, 2022

MAPTA

912011163MAPTAZ5

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: EBG MedAustron GmbH
UDI-DI code: 09120111630017
Reference / catalog number: UMDNS/GMDN 13279

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Manufacturer information

Organization name: EBG MedAustron GmbH
SRN: AT-MF-000002630
Manufacturer status: Active

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW133
EUDAMED did not publish a description for this code.
CW028
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Austria; available across 1 country total.

Country	On market since	Until
AustriaPrimary placement	Dec 14, 2016	Still on market

Device identification

Trade name: MAPTA
UDI-DI code: 09120111630017
Basic UDI-DI: 912011163MAPTAZ5
Reference / catalog number: UMDNS/GMDN 13279
Issuing entity: GS1

Classification

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

Device details

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

EMDN nomenclature code(s)

Z11019099VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - 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

Related devices

MATEO912011163MATEOZ8On the market

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.