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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

SP0138 — Class I MDR by PS Product Services GmbH

MD Atlas
PS Product Services GmbH

EUDAMED last updated this device on May 10, 2024

SP0138

4050235PS0002BC

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: PS Product Services GmbH
UDI-DI code: 04050235003358
Reference / catalog number: SP0138

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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.

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

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: 04050235003358
Basic UDI-DI: 4050235PS0002BC
Reference / catalog number: SP0138
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: Handgelenkbandage
Additional information URL: https://www.product-services.de/downloads/
Clinical sizes: Größe L/XL

EMDN nomenclature code(s)

M0399BANDAGES - OTHER (see Y06 for collars, tutors, etc.)

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