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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

Ainone Balance — Class I MDD by Ain1 Oy

MD Atlas
Ain1 Oy

EUDAMED last updated this device on Dec 16, 2022

Ainone Balance

B-AinoneBalance7U

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Ain1 Oy
UDI-DI code: D-AinoneBalance7U
Reference / catalog number: FI-CA01-2019-0569

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Manufacturer information

Organization name: Ain1 Oy
SRN: FI-MF-000019173
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: Ainone Balance
UDI-DI code: D-AinoneBalance7U
Basic UDI-DI: B-AinoneBalance7U
Reference / catalog number: FI-CA01-2019-0569
Issuing entity: EUDAMED

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Balance Assessment
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V030299DIMENSIONAL CLINICAL PARAMETERS MEASURING DEVICES - OTHER

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

This device is not currently linked to any other device.

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.