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

HSOMASA20 — Class I MDR by Rudolf Heintel…

MD Atlas
Rudolf Heintel Gesellschaft m.b.H.

EUDAMED last updated this device on Feb 2, 2026

HSOMASA20

912004788-HSOMASA-WF

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: 09120047885314
Reference / catalog number: HSOMASA20

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

Related devices

HSOMASA4912004788-HSOMASA-WFOn the market HSOTRFIX4000912004788-HSOTRFIX-QWOn the market HSOOPFIX800912004788-HSOOPFIX-N7On the market HSOOPFIX1000P912004788-HSOOPFIX-N7On the market HSOOPFIX1000912004788-HSOOPFIX-N7On the market

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: 09120047885314
Basic UDI-DI: 912004788-HSOMASA-WF
Reference / catalog number: HSOMASA20
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: 20
Additional product description: The product is designed to reduce friction and pressure caused by clothing, thereby minimizing chafing, pain, and other irritation on sensitive or sore nipples.
Additional information URL: https://www.hso-solutions.at/en/portfolio/detail/mamasafe
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M040499DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - 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.