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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

203100 — Class I MDR by i3 Membrane GmbH

MD Atlas
i3 Membrane GmbH

EUDAMED last updated this device on Jun 15, 2023

203100

4260632192031008Y

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: i3 Membrane GmbH
UDI-DI code: 04260632190043
Reference / catalog number: 203100

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Manufacturer information

Organization name: i3 Membrane GmbH
SRN: DE-MF-000007284
Manufacturer status: Active

Related devices

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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
Read the instructions thoroughly before use
CW007
Do not use if the filter or the packaging is damaged
CW032
Do not use after the expiry date

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: 04260632190043
Basic UDI-DI: 4260632192031008Y
Reference / catalog number: 203100
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: The i3 ONE point-of-use sterile filter is used in medical settings to prevent infections caused by bacteria such as Legionella pneumophila, Pseudomonas aeruginosa and mycobacteria. It is used on the water faucet for the sterile filtration of tap water. The water filter protects patients receiving medical treatment, for example in oncological, transplant and intensive care wards, and also neonates, from infections caused by waterborne pathogens.
Additional information URL: https://www.i3membrane.de/en/medical/sterile-filtration/i3-one/
Clinical sizes: No clinical sizes registered for this device.

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