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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

HSOPF22H — Class I MDR by Rudolf Heintel…

MD Atlas
Rudolf Heintel Gesellschaft m.b.H.

EUDAMED last updated this device on Dec 18, 2025

HSOPF22H

912004788-HSOPF-5V

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Rudolf Heintel Gesellschaft m.b.H.
UDI-DI code: 09120047885017
Reference / catalog number: HSOPF22H

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Manufacturer information

Organization name: Rudolf Heintel Gesellschaft m.b.H.
SRN: AT-MF-000050568
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.

Market distribution

Primary placement in Austria; available across 1 country total.

Placed on the market in Austria; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 09120047885017
Basic UDI-DI: 912004788-HSOPF-5V
Reference / catalog number: HSOPF22H
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: The product is a fixation splint for stabilizing hand joints in adult patients with arterial accesses and peripheral infusions. It serves to prevent unwanted bending of the joint, thereby reducing pain or slippage of arterial accesses.
Additional information URL: https://www.hso-solutions.at/en/portfolio/detail/profix
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M030599IMMOBILISATION SYSTEMS AND 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

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