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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

Zensiv — Class I MDR by Oxmed International GmbH

MD Atlas
Oxmed International GmbH

EUDAMED last updated this device on Apr 30, 2026

Zensiv

426033315C1-FV2

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Oxmed International GmbH
UDI-DI code: 04260333150148
Reference / catalog number: C1NB10

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Manufacturer information

Organization name: Oxmed International GmbH
SRN: DE-MF-000004970
Manufacturer status: Active

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Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

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	Jan 1, 2014	Still on market

Device identification

Trade name: Zensiv
UDI-DI code: 04260333150148
Basic UDI-DI: 426033315C1-FV2
Reference / catalog number: C1NB10
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: 20
Additional product description: Zensiv 1-p colo beige window filter ctf: Ostomy pouches are used to collect waste from the body and are usually attached to the skin over a surgically made stoma.
Additional information URL: https://oxmed.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

A1001010102ONE-PIECE COLOSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT, WITH TISSUE COVER

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.