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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

3mensio Workstation — Class IIa MDD by Pie Medical Imaging B.V.

MD Atlas
Pie Medical Imaging B.V.

EUDAMED last updated this device on Sep 27, 2022

3mensio Workstation

B-08056304453495

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Pie Medical Imaging B.V.
UDI-DI code: 08056304453495
Reference / catalog number: 6.1

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Manufacturer information

Organization name: Pie Medical Imaging B.V.
SRN: NL-MF-000001540
Manufacturer status: Active

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3mensio WorkstationB-08056304454225On the market 3mensio WorkstationB-08056304454072On the market 3mensio WorkstationB-08056304453839On the market 3mensio WorkstationB-08056304453778On the market 3mensio WorkstationB-08056304454249On 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.

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Netherlands; available across 1 country total.

Country	On market since	Until
NetherlandsPrimary placement	Jun 22, 2017	Still on market

Device identification

Trade name: 3mensio Workstation
UDI-DI code: 08056304453495
Basic UDI-DI: B-08056304453495
Reference / catalog number: 6.1
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://www.piemedicalimaging.com/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

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

Z11039082VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - SOFTWARE ACCESSORIES

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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