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Organization name
UDI-DI code
Reference / catalog number

HSO08 — Class I MDR by MSP Medizintechnik GmbH

MD Atlas
MSP Medizintechnik GmbH

EUDAMED last updated this device on Aug 9, 2022

HSO08

912004788HSOFERSENFIXBU

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MSP Medizintechnik GmbH
UDI-DI code: 09120047882627
Reference / catalog number: HSO08

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Manufacturer information

Organization name: MSP Medizintechnik GmbH
SRN: AT-MF-000018341
Manufacturer status: Inactive

Critical warnings

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

CW007
EUDAMED did not publish a description for this code.

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: 09120047882627
Basic UDI-DI: 912004788HSOFERSENFIXBU
Reference / catalog number: HSO08
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: FersenFix ist ein einteiliger – aus hautfreundlichem Schaumstoff hergestellter – Fersenschutz, der in allen Bereichen der Patientenlagerung eingesetzt werden kann. Die wirkungsvolle Entlastung der Extremitäten sowie der präventive Einsatz zur Vermeidung von Druckstellen, minimiert die Dekubitusgefahr einerseits und trägt andererseits zum Komfort des Patienten bei. Die Lagerungshilfe kann zudem auch im Zuge plastischer Operationen direkt im OP 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)

V0811HEEL, ELBOW AND KNEE ANTI-DECUBITUS PROTECTION AIDS

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

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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.