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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

P43778 — Class I MDR by SOFTLINE-Schaum GmbH &…

MD Atlas
SOFTLINE-Schaum GmbH & Co. KG

EUDAMED last updated this device on May 29, 2024

P43778

4056538POS001SJ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SOFTLINE-Schaum GmbH & Co. KG
UDI-DI code: 04056538004962
Reference / catalog number: P43778

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Manufacturer information

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

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: 04056538004962
Basic UDI-DI: 4056538POS001SJ
Reference / catalog number: P43778
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 zylindrisch-geformtes Positionierungshilfe, bestehend aus einer bi-elastischen polyurethanbeschichteten Hülle und einer Füllung aus Mikropolystyrolkugeln, kann variabel zur Abstützung des Rumpfes bzw. zur Lagerungsunterstützung der Beine eingesetzt werden.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V080302PATIENT POSITIONING MEDICAL CUSHIONS

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
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Software identification