Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

ST9310-Hi5-MD Abdomen/Back Easy… — Class I MDR by Ab HUR Oy

MD Atlas
Ab HUR Oy

EUDAMED last updated this device on Dec 28, 2022

ST9310-Hi5-MD Abdomen/Back Easy Access

642981020317201G8

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Ab HUR Oy
UDI-DI code: 06429810203274
Reference / catalog number: ST9310-Hi5-MD

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Related devices

2032 HUR SmartBalance642981020311623FUOn the market 2204 Balance Trainer BTG4642981020311623FUOn the market 5110 Biceps/Triceps642981020311625FYOn the market 5120 Push Up/Pull Down Rehab642981020311636G5On the market 5125 Dip/Shrug642981020311636G5On the market

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 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: ST9310-Hi5-MD Abdomen/Back Easy Access
UDI-DI code: 06429810203274
Basic UDI-DI: 642981020317201G8
Reference / catalog number: ST9310-Hi5-MD
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 vatsan ja selän lihasvoiman parantamiseen ja ylläpitämiseen. 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