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

HSOSAFIX3000 — Class I MDR by Rudolf Heintel…

MD Atlas
Rudolf Heintel Gesellschaft m.b.H.

EUDAMED last updated this device on Feb 2, 2026

HSOSAFIX3000

912004788-HSOSAFIX-JN

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: 09120047885192
Reference / catalog number: HSOSAFIX3000

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: Rudolf Heintel Gesellschaft m.b.H.
SRN: AT-MF-000050568
Manufacturer status: Active

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: 09120047885192
Basic UDI-DI: 912004788-HSOSAFIX-JN
Reference / catalog number: HSOSAFIX3000
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: SafeFix is intended to prevent the manipulation or accidental removal of infusions, catheters, drains, or medical devices with the fingers, as well as to protect against self-harm in cases of highly agitated patient behavior.
Additional information URL: https://www.hso-solutions.at/en/portfolio/detail/safefix
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V0804PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)

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

Related devices

HSOMASA4912004788-HSOMASA-WFOn the market HSOTRFIX4000912004788-HSOTRFIX-QWOn the market HSOMASA20912004788-HSOMASA-WFOn the market HSOOPFIX800912004788-HSOOPFIX-N7On the market HSOOPFIX1000P912004788-HSOOPFIX-N7On 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.