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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

SP0105 — Class I MDR by PS Product Services GmbH

MD Atlas
PS Product Services GmbH

EUDAMED last updated this device on Dec 1, 2021

SP0105

4050235PS0002BC

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: PS Product Services GmbH
UDI-DI code: 04050235000067
Reference / catalog number: SP0105

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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

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW135
EUDAMED did not publish a description for this code.
CW277
EUDAMED did not publish a description for this code.
CW162
Vor dem ersten und jeweils nach 2-3 Anwendungen waschen.

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: 04050235000067
Basic UDI-DI: 4050235PS0002BC
Reference / catalog number: SP0105
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: Fußgelenk-Bandage zur Stabilisierung und Entlastung schwacher oder schmerzender Fußgelenke
Additional information URL: https://www.product-services.de/gebrauchsanweisungen/
Clinical sizes: Größe M, Fesselumfang ca. 20-24cm

EMDN nomenclature code(s)

M030499ELASTIC BANDAGES, SUPPORT AND COMPRESSION - 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

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.