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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

8821 HUR Pulley (max. 20 kg) free… — Class I MDR by Ab HUR Oy

MD Atlas
Ab HUR Oy

EUDAMED last updated this device on Dec 28, 2022

8821 HUR Pulley (max. 20 kg) free standing

642981020311625FY

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Ab HUR Oy
UDI-DI code: 06429810203618
Reference / catalog number: 8821

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Manufacturer information

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

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Critical warnings

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

CW999
See user 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: 8821 HUR Pulley (max. 20 kg) free standing
UDI-DI code: 06429810203618
Basic UDI-DI: 642981020311625FY
Reference / catalog number: 8821
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: Kuntoilulaite, joka on tarkoitettu toiminnalliseen harjoitteluun. HUR:n valmistamat voimaharjoittelulaitteet on tarkoitettu kehittämään ja ylläpitämään tahdonalaisesti tuotettua lihasvoimaa eri kehon osissa. Kaikkia HUR:n voimaharjoittelulaitteita voidaan käyttää liitännäishoitona lisäämään ja ylläpitämään lihasvoimaa kansainvälisten terveyden edistämisen, sairauksien hoidon ja ennaltaehkäisyn, sekä kuntoutuksen suositusten mukaisesti.
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
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.