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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

Tensogel adhesive electrodes — Class I MDR by Fysiomed NV

MD Atlas
Fysiomed NV

EUDAMED last updated this device on Dec 9, 2022

Tensogel adhesive electrodes

54199880318137633SR

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Fysiomed NV
UDI-DI code: 05419980318121
Reference / catalog number: 37633

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Manufacturer information

Organization name: Fysiomed NV
SRN: BE-MF-000014942
Manufacturer status: Inactive

Market distribution

Primary placement in Belgium; available across 1 country total.

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

Device identification

Trade name: Tensogel adhesive electrodes
UDI-DI code: 05419980318121
Basic UDI-DI: 54199880318137633SR
Reference / catalog number: 37633
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Tensogel adhesive electrodes package of 4 size of each electrode 5 x 9 cm
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12062885NEUROMUSCULAR STIMULATION EQUIPMENT - CONSUMABLES

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

11165B-05419980318138On the market Tensogel adhesive electrodes54199880318137632SPOn the market Tensogel adhesive electrodes54199880318137630SKOn 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.