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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

158.12 — Class IIa MDR by OIARSO, S. COOP

MD Atlas
OIARSO, S. COOP

EUDAMED last updated this device on Mar 16, 2026

158.12

8427860SFP2100000022ASQ

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: OIARSO, S. COOP
UDI-DI code: 08427860158122
Reference / catalog number: 158.12

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Manufacturer information

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

Related devices

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

Critical warnings

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

CW007
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, con protecciones sueltas, con sangre ni hemoderivados. 2. No reutilizar ni reesterilizar.

Market distribution

Primary placement in Spain; available across 2 countries total.

Country	On market since	Until
SpainPrimary placement	Sep 27, 2024	Still on market
Portugal		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08427860158122
Basic UDI-DI: 8427860SFP2100000022ASQ
Reference / catalog number: 158.12
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: SOLUTION FILTER 1.2 MICRONS LUER LOCK CONNECTION COMPATIBLE WITH PUMP
Additional information URL: https://bexen.com/biblioteca/#anchor-des-instrucciones
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

A04010101WITHDRAWL AND ADMINISTRATION FILTERS (0.2-1.2 MICRONS)

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.