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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

01-100 — Class IIa MDD by AthenaDiaX GmbH

MD Atlas
AthenaDiaX GmbH

EUDAMED last updated this device on Mar 16, 2023

01-100

B-04260732640035

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: AthenaDiaX GmbH
UDI-DI code: 04260732640035
Reference / catalog number: 01-100

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Manufacturer information

Organization name: AthenaDiaX GmbH
SRN: DE-MF-000033821
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW027
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement	Sep 18, 2013	Still on market
Italy	Sep 18, 2013	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260732640035
Basic UDI-DI: B-04260732640035
Reference / catalog number: 01-100
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: Wearable sensor for long term recording of heart signals
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12050403ECG HOLTER RECORDERS

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

02-100B-04260732640042On 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.