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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

KM43329 — Class I MDR by SOFTLINE-Schaum GmbH &…

MD Atlas
SOFTLINE-Schaum GmbH & Co. KG

EUDAMED last updated this device on Jul 2, 2024

KM43329

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: 04056538004696
Reference / catalog number: KM43329

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Manufacturer information

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

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

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: 04056538004696
Basic UDI-DI: 4056538MAT005LY
Reference / catalog number: KM43329
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® CARGUMAX ist eine dreischichtig aufgebaute Matratze mit Vollschutzbezug. Sie besteht aus zwei stützenden Polyurethanschaumstoffschichten, wobei die obere Stützschicht mit einer antibakteriell ausgestatteten viscoelastischen Liegefläche verbunden ist. Zusätzlich ist der Schaumstoffkern mit einer verstärkten Randzone und 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

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.