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Organization name
UDI-DI code
Reference / catalog number

FP0031 — Class I MDR by PS Product Services GmbH

MD Atlas
PS Product Services GmbH

EUDAMED last updated this device on Jun 16, 2025

FP0031

4050235PS0004BG

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: PS Product Services GmbH
UDI-DI code: 04050235002856
Reference / catalog number: FP0031

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Manufacturer information

Organization name: PS Product Services GmbH
SRN: DE-MF-000005290
Manufacturer status: Active

Related devices

FP00354050235PS0004BGOn the market FP00354050235PS0004BGOn the market FP00354050235PS0004BGOn the market FP00354050235PS0004BGOn the market FP00094050235PS0004BGOn 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.

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW162
EUDAMED did not publish a description for this code.
CW999
W przypadku cukrzycy, zaburzeń krążenia lub chorób skóry przed użyciem należy skonsultować się z lekarzem.
CW999
- Materiały opakowaniowe oraz produkt należy trzymać z dala od małych dzieci. Istnieje m.in. niebezpieczeństwo uduszenia! - W razie wystąpienia zaczerwienienia, opuchlizny lub utrzymującego się bólu, produkt należy natychmiast zdjąć. Produkt nie może ograniczać dopływu krwi. Nie może być noszony w czasie snu ani przez osoby, które nie są w stanie zgłosić ewentualnych problemów związanych z jego noszeniem. - Produkt stosować wyłącznie na nieuszkodzoną skórę, nie stosować na zranienia ani otwarte rany. Skóra nie może być pokryta olejkami, maściami, kremami itp. - Poważne przypadki negatywnego wpływu na zdrowie należy zgłaszać producentowi oraz właściwemu urzędowi.

Market distribution

Primary placement in Poland; available across 2 countries total.

Country	On market since	Until
PolandPrimary placement	Jul 3, 2023	Still on market
Portugal	Jul 19, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04050235002856
Basic UDI-DI: 4050235PS0004BG
Reference / catalog number: FP0031
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: 2
Additional product description: Osłona ochronna na piętę
Additional information URL: https://www.product-services.de/download/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - 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

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Software identification