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Organization name
UDI-DI code
Reference / catalog number

1601097-001 — Class IIa MDR by Bien-Air Dental SA

MD Atlas
Bien-Air Dental SA

EUDAMED last updated this device on Jul 1, 2025

1601097-001

++J007EMOT0001UH

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Bien-Air Dental SA
UDI-DI code: J00716010970011
Reference / catalog number: 1601097-001

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Manufacturer information

Organization name: Bien-Air Dental SA
SRN: CH-MF-000014661
Manufacturer status: Active

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1600436-001++J007CAHP0001GQOn the market 1600362-001B-J00716003620011On the market 1600811-001++J007EMOT0001UHOn the market 1600982-005++J007EMOT0001UHOn the market 1600903-00A++J007EMOT0001UHOn the market

Market distribution

Primary placement in Finland; available across 1 country total.

Country	On market since	Until
FinlandPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: J00716010970011
Basic UDI-DI: ++J007EMOT0001UH
Reference / catalog number: 1601097-001
Issuing entity: HIBCC

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: The hoses, also called “tuyaux” (“TY”), are accessories used to connect the micromotor to a dental unit or to a table-top device. For all hoses, the main function is to deliver electrical power, air and water to the micromotor. Some hoses are private label for specific clients, in this case the product designation is followed by the corresponding client number. None of the hoses is sterilisable and cannot be cleaned in a thermo-washer disinfectable. Depending on the type of the motor they are connected to, different hoses or cables can be used.
Additional information URL: https://dental.bienair.com/en_ch/support/download-center/
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

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.