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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

4631 — Class I MDR by Sterisol AB

MD Atlas
Sterisol AB

EUDAMED last updated this device on May 4, 2026

4631

73921731051RJ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Sterisol AB
UDI-DI code: 07392173046316
Reference / catalog number: 4631

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View device family (Basic UDI)

Manufacturer information

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

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Sterisol Rincage Oculaire73921731051RJOn the market 28001973921731051RJOn 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 Sweden; available across 1 country total.

Country	On market since	Until
SwedenPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 07392173046316
Basic UDI-DI: 73921731051RJ
Reference / catalog number: 4631
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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