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Organization name
UDI-DI code
Reference / catalog number

2032 HUR SmartBalance — Class I MDR by Ab HUR Oy

MD Atlas
Ab HUR Oy

EUDAMED last updated this device on Jun 24, 2024

2032 HUR SmartBalance

642981020311623FU

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Ab HUR Oy
UDI-DI code: 06429810203816
Reference / catalog number: 2032

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Manufacturer information

Organization name: Ab HUR Oy
SRN: FI-MF-000008012
Manufacturer status: Active

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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.

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW999
See manual

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: 2032 HUR SmartBalance
UDI-DI code: 06429810203816
Basic UDI-DI: 642981020311623FU
Reference / catalog number: 2032
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: SmartBalance is a balance platform equipped with support rails designed to scientifically assess and enhance an individual's balance. Utilizing scientifically proven tests, results are stored in a database for analysis. For training, it offers engaging games and activities specifically designed to improve balance through step movements and weight shifting.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y0599LEARNING AND TRAINING 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
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Software identification