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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

digipaX 2.2.1 — Class IIb MDR by digipaX GmbH

MD Atlas
digipaX GmbH

EUDAMED last updated this device on Oct 28, 2024

digipaX 2.2.1

42700037058DPX0202UC

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: digipaX GmbH
UDI-DI code: 04270003705813
Reference / catalog number: digipaX 2.2.1

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Manufacturer information

Organization name: digipaX GmbH
SRN: DE-MF-000007237
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement		Still on market
Poland		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04270003705813
Basic UDI-DI: 42700037058DPX0202UC
Reference / catalog number: digipaX 2.2.1
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z110603PICTURE ARCHIVING AND COMMUNICATION SYSTEMS

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.