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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

DDS/FIX 002 — Class IIb MDR by FONDAZIONE CENTRO…

MD Atlas
FONDAZIONE CENTRO NAZIONALE DI ADROTERAPIA ONCOLOGICA

EUDAMED last updated this device on Oct 7, 2022

DDS/FIX 002

805415466_DDS/FIX_K7

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: FONDAZIONE CENTRO NAZIONALE DI ADROTERAPIA ONCOLOGICA
UDI-DI code: 08054154660025
Reference / catalog number: DDS/FIX 002

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View device family (Basic UDI)

Manufacturer information

Organization name: FONDAZIONE CENTRO NAZIONALE DI ADROTERAPIA ONCOLOGICA
SRN: IT-MF-000021295
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Austria; available across 1 country total.

Country	On market since	Until
AustriaPrimary placement	Feb 29, 2016	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08054154660025
Basic UDI-DI: 805415466_DDS/FIX_K7
Reference / catalog number: DDS/FIX 002
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: Dose Delivery System (DDS) is a medical device that monitors and controls the distribution of the dose during radiotherapy treatment with protons and / or carbon ions
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08054154660025

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

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

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Related devices

CNAO-01805415466_CNAO-01_EPOn the market DDS/FIX 004805415466_DDS/FIX_K7On the market DDS/GAN 005805415466_DDS/GAN_H8On the market DDS/FIX 003805415466_DDS/FIX_K7On the market DDS/FIX805415466_DDS/FIX_K7On the market

Certificates

Certificate health across this manufacturer's portfolio.

CVP0005220225Amended
Product VerificationNotified body: 0373Expiry: Aug 3, 2027
CVP0003220225Amended
Product VerificationNotified body: 0373Expiry: Aug 3, 2027
CVP0001220225Amended
Product VerificationNotified body: 0373Expiry: Aug 3, 2027
CVP0006230225Amended
Product VerificationNotified body: 0373Expiry: Apr 5, 2028
CVP0004220225Amended
Product VerificationNotified body: 0373Expiry: Aug 3, 2027
CVP0002220225Amended
Product VerificationNotified body: 0373Expiry: Aug 3, 2027