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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

280019 — Class I MDR by Sterisol AB

MD Atlas
Sterisol AB

EUDAMED last updated this device on May 26, 2026

280019

73921731051RJ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Sterisol AB
UDI-DI code: 04052677996786
Reference / catalog number: 280019

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View device family (Basic UDI)

Manufacturer information

Organization name: Sterisol AB
SRN: SE-MF-000019930
Manufacturer status: Active

Related devices

463173921731051RJOn the market Sterisol Rincage Oculaire73921731051RJOn the market 463573921731051RJOn the market 464173921731051RJOn the market 462573921731051RJOn the market

Certificates

Certificate health across this manufacturer's portfolio.

C541396Issued
Quality assuranceNotified body: 2460Expiry: Aug 25, 2027

Critical warnings

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

CW009
Single use only

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Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04052677996786
Basic UDI-DI: 73921731051RJ
Reference / catalog number: 280019
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

A03040202OCULAR 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

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