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

KM46248 — Class I MDR by SOFTLINE-Schaum GmbH &…

MD Atlas
SOFTLINE-Schaum GmbH & Co. KG

EUDAMED last updated this device on Jul 5, 2024

KM46248

4056538MAT005LY

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SOFTLINE-Schaum GmbH & Co. KG
UDI-DI code: 04056538006942
Reference / catalog number: KM46248

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: SOFTLINE-Schaum GmbH & Co. KG
SRN: DE-MF-000014549
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 04056538006942
Basic UDI-DI: 4056538MAT005LY
Reference / catalog number: KM46248
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: Die CliniMat® MIXT PRO ist eine zweischichtig aufgebaute Matratze mit Vollschutzbezug, bestehend aus einer hochwertigen HR-Schaumstoff-Stützschicht mit Quereinschnitten und einer speziellen Weichlagerungsliegefläche. Sie ist mit einer verstärkten Randzone mit Duplexeinschnitten ausgestattet.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V080702NON ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES

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

P438074056538POS001SJOn the market P438064056538POS001SJOn the market P442724056538POS003SNOn the market SO-M245244056538MAT003LUOn the market SO-M240244056538MAT003LUOn 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.