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Organization name
UDI-DI code
Reference / catalog number

520.028 — Class IIa MDD by preOx.RS GmbH

MD Atlas
preOx.RS GmbH

EUDAMED last updated this device on Apr 30, 2025

520.028

B-04260702150465

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: preOx.RS GmbH
UDI-DI code: 04260702150465
Reference / catalog number: 520.028

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Manufacturer information

Organization name: preOx.RS GmbH
SRN: DE-MF-000005017
Manufacturer status: Active

Related devices

200.103B-04260702150175On the market preOx - HUTB-04260702150168On the market 200.050B-04260702150113On the market 200.104B-04260702150182On the market 200.060B-04260702150120On 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.

CW009
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260702150465
Basic UDI-DI: B-04260702150465
Reference / catalog number: 520.028
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Catheter for Interpleural Irrigation with Trocar
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: gerade, Zuspritzlumen 3 Seitenlöcher
CH 28

EMDN nomenclature code(s)

A0699DRAINAGE AND FLUID COLLECTION DEVICES - 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