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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

F1 ENT — Class I MDR by Fimet Oy

MD Atlas
Fimet Oy

EUDAMED last updated this device on Feb 26, 2025

F1 ENT

6429810585DentalchairQJ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Fimet Oy
UDI-DI code: 06429810585028
Reference / catalog number: F1 ENT

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Manufacturer information

Organization name: Fimet Oy
SRN: FI-MF-000006831
Manufacturer status: Active

Market distribution

Primary placement in Finland; available across 1 country total.

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

Device identification

Trade name: F1 ENT
UDI-DI code: 06429810585028
Basic UDI-DI: 6429810585DentalchairQJ
Reference / catalog number: F1 ENT
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: The Fimet Dental Treatment System is intended for the diagnosis, therapy, and all kinds of dental treatment of persons by trained dental care professionals. The patient chair can be used to administer dental, ear, nose and throat, foot, cosmetic, and other similar treatments.
Additional information URL: https://www.fimet.fi/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12110101DENTAL TREATMENT UNITS

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

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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.