Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

1097-022 — Class IIa MDR by Novafon Elektromedizinis…

MD Atlas
Novafon Elektromedizinische Geräte GmbH

EUDAMED last updated this device on May 22, 2023

1097-022

426020379NOVAFONSKGS

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Novafon Elektromedizinische Geräte GmbH
UDI-DI code: 04260203792843
Reference / catalog number: 1097-022

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

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: 04260203792843
Basic UDI-DI: 426020379NOVAFONSKGS
Reference / catalog number: 1097-022
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
Serial number
Software identification

Related devices

adapter black426020379SensiN5On the market adapter gray426020379SensiN5On the market adapter white426020379SensiN5On the market clip black426020379SensiN5On the market clip gray426020379SensiN5On 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.