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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

FP0022 — Class I MDR by PS Product Services GmbH

MD Atlas
PS Product Services GmbH

EUDAMED last updated this device on Jun 24, 2025

FP0022

4050235PS0006BL

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: PS Product Services GmbH
UDI-DI code: 04050235001675
Reference / catalog number: FP0022

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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
Bei Diabetes, Durchblutungsstörungen oder Hautkrankheiten klären Sie die Anwendung vorher mit Ihrem Arzt ab.
CW999
- Halten Sie Kleinkinder von Artikel und Verpackungsmaterial fern. Es besteht u.a. Erstickungsgefahr! - Bei Rötung, Schwellung oder anhaltenden Schmerzen den Artikel sofort entfernen. Der Artikel darf die Blutzufuhr nicht einschränken. Er darf nicht während des Schlafens und nicht von Personen, die sich nicht bemerkbar machen können, getragen werden. - Den Artikel nur auf intakter, unverletzter Haut anwenden. Die Haut muss frei von Ölen, Salben, Cremes etc. sein. - Schwerwiegende Vorfälle sind dem Hersteller und der zuständigen Behörde zu melden.

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: 04050235001675
Basic UDI-DI: 4050235PS0006BL
Reference / catalog number: FP0022
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: Hallux-Valgus-Bandage
Additional information URL: https://www.product-services.de/download/
Clinical sizes: S/M

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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification