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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

091.06 — Class I MDR by OIARSO, S. COOP

MD Atlas
OIARSO, S. COOP

EUDAMED last updated this device on Mar 26, 2026

091.06

8427860URO2100000021ABM

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: OIARSO, S. COOP
UDI-DI code: 08427860091061
Reference / catalog number: 091.06

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Manufacturer information

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

Critical warnings

4 warnings recorded — scroll inside the panel to see all entries.

CW007
1. Do not use: with broken or damaged packaging, if the protective caps are loose, with blood or haemoderivates
CW009
EUDAMED did not publish a description for this code.
CW001
EUDAMED did not publish a description for this code.
CW999
1. No utilizar: con envase perforado o dañado, con protecciones sueltas, con sangre ni hemoderivados. 2. No reutilizar ni reesterilizar

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	May 22, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08427860091061
Basic UDI-DI: 8427860URO2100000021ABM
Reference / catalog number: 091.06
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: -IRRIGATION SET -DOUBLE FILLING LINE -MULTIPLE CONNECTOR -NOT COMPATIBLE WITH HIGH VISCOSITY SOLUTIONS ADMINISTERED AT HIGH RATE -MAXIMUN USING TIME 24 HOURS
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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

158.028427860SFP2100000022ASQOn the market 850.078427860CAR10010000510X5On the market 137.03B-ESMF00000086613703DDOn the market 091.03B-ESMF00000086609103DEOn the market 850.098427860STF1100000021AY2On 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.