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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

HSO08 — Class I MDR by Rudolf Heintel…

MD Atlas
Rudolf Heintel Gesellschaft m.b.H.

EUDAMED last updated this device on Dec 18, 2025

HSO08

912004788-HSOFERSENFIX-MK

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: 09120047885116
Reference / catalog number: HSO08

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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: 09120047885116
Basic UDI-DI: 912004788-HSOFERSENFIX-MK
Reference / catalog number: HSO08
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: FersenFix is a heel protector designed to relieve pressure on the heels and prevent pressure sores and decubitus in patients of all ages.
Additional information URL: https://www.hso-solutions.at/sortiment/detail/fersenfix
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V0811HEEL, ELBOW AND KNEE ANTI-DECUBITUS PROTECTION AIDS

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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Expiration date
Manufacturing date
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Software identification