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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

5.8.1 — Class I MDD by Phönix-PACS GmbH

MD Atlas
Phönix-PACS GmbH

EUDAMED last updated this device on Jan 28, 2026

5.8.1

B-1311643DW05821

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Phönix-PACS GmbH
UDI-DI code: 1311643DW05821
Reference / catalog number: 5.8.1

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Manufacturer information

Organization name: Phönix-PACS GmbH
SRN: DE-MF-000005785
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 1311643DW05821
Basic UDI-DI: B-1311643DW05821
Reference / catalog number: 5.8.1
Issuing entity: IFA

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC 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)

Z11069092VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE

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

7.0B-1311643DW070031On the market 7.3B-1311643DW073070On the market 7.1B-1311643DW071044On the market 7.4B-1311643DW074083On 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.