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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

OUATE HYDROPHILE — Class I MDR by Alan & Co

MD Atlas
Alan & Co

EUDAMED last updated this device on Nov 26, 2025

OUATE HYDROPHILE

542503254OU000ZD

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Alan & Co
UDI-DI code: 05425032542130
Reference / catalog number: OU100GALFL

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Manufacturer information

Organization name: Alan & Co
SRN: BE-MF-000000141
Manufacturer status: Active

Critical warnings

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

CW009
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement		Dec 31, 2099

Device identification

Trade name: OUATE HYDROPHILE
UDI-DI code: 05425032542130
Basic UDI-DI: 542503254OU000ZD
Reference / catalog number: OU100GALFL
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: SACHETS DE 100 GR D'OUATE HYDROPHILE ALFALUX
Additional information URL: https://www.alanmedical.be/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M010101HYDROPHILIC COTTON

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

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.