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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

375.00 — Class I MDR by OIARSO, S. COOP

MD Atlas
OIARSO, S. COOP

EUDAMED last updated this device on Mar 12, 2026

375.00

8427860REC2100000021A8Y

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: OIARSO, S. COOP
UDI-DI code: 08427860375000
Reference / catalog number: 375.00

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Manufacturer information

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

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Critical warnings

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

CW007
Do not use if packaging is damaged or protection caps are loose.
CW009
EUDAMED did not publish a description for this code.
CW001
EUDAMED did not publish a description for this code.
CW999
Replace the set if one of the following conditions applies: - After 8 hours of use. - After transferring 1 litre of diluent. - When changing diluent types.

Market distribution

Primary placement in Spain; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 08427860375000
Basic UDI-DI: 8427860REC2100000021A8Y
Reference / catalog number: 375.00
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: RECONSTITUTION SET Non-pyrogenic
Additional information URL: https://bexen.com/biblioteca/#anchor-des-instrucciones
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

A0704SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS

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.