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Organization name
UDI-DI code
Reference / catalog number

01.P.30.00 — Class IIa MDD by iSEKS diagnostics GmbH

MD Atlas
iSEKS diagnostics GmbH

EUDAMED last updated this device on Dec 9, 2024

01.P.30.00

B-iSEKS-EcgEH

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: iSEKS diagnostics GmbH
UDI-DI code: D-iSEKS-EcgEH
Reference / catalog number: 01.P.30.00

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Manufacturer information

Organization name: iSEKS diagnostics GmbH
SRN: DE-MF-000016478
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Apr 16, 2020	Still on market

Device identification

Trade name: not provided
UDI-DI code: D-iSEKS-EcgEH
Basic UDI-DI: B-iSEKS-EcgEH
Reference / catalog number: 01.P.30.00
Issuing entity: EUDAMED

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://ecg.iseks.de/eIFU
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12050392ELECTROCARDIOGRAPHS - 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

This device is not currently linked to any other device.

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.