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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

380.20 — Class I MDR by OIARSO, S. COOP

MD Atlas
OIARSO, S. COOP

EUDAMED last updated this device on Mar 26, 2026

380.20

8427860URO2100000021ABM

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: OIARSO, S. COOP
UDI-DI code: 08427860380202
Reference / catalog number: 380.20

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Manufacturer information

Organization name: OIARSO, S. COOP
SRN: ES-MF-000000866
Manufacturer status: Active

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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

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

CW999
1. NE PAS UTILISER: -Si les protections sont détachées. -Pour le sang et les dérivés sanguins. 2. Ne pas utiliser par voie intraveineuse. 3. Ne pas réutiliser ni restériliser après utilisation.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Apr 2, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08427860380202
Basic UDI-DI: 8427860URO2100000021ABM
Reference / catalog number: 380.20
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: SYSTEME UROLOGIQUE Tubulure B / URO / Y2 -NÉCESSAIRE EN Y POUR IRRIGATION VÉSICALE CONTINUE PER ET POST OPÉRATOIRE ET RÉSECTION TRANSURÉTRALE. -NE PAS UTILISER CHEZ L'ENFANT OU CHEZ LA FEMME ENCEINTE OU ALLAITANTE. -UTILISATION MAXIMALE: 24 HEURES.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

A03040201BLADDER IRRIGATION KITS, SINGLE-USE

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

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Expiration date
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Software identification