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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

1097-024 — Class IIa MDR by Novafon Elektromedizinis…

MD Atlas
Novafon Elektromedizinische Geräte GmbH

EUDAMED last updated this device on May 22, 2023

1097-024

426020379NOVAFONSKGS

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Novafon Elektromedizinische Geräte GmbH
UDI-DI code: 04260203792850
Reference / catalog number: 1097-024

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Manufacturer information

Organization name: Novafon Elektromedizinische Geräte GmbH
SRN: DE-MF-000006137
Manufacturer status: Active

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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.

Critical warnings

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

CW011
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	May 11, 2023	Still on market
Austria	May 11, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260203792850
Basic UDI-DI: 426020379NOVAFONSKGS
Reference / catalog number: 1097-024
Issuing entity: GS1

Classification

Risk category: Class IIa
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)

Z120612ENDORAL ELECTRIC MASSAGE EQUIPMENT

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
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Software identification