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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

Waaler Rose — IVDD — General IVDD by Cypress Diagnostics

MD Atlas
Cypress Diagnostics

EUDAMED last updated this device on Mar 19, 2026

Waaler Rose

B-05404035100844

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Cypress Diagnostics
UDI-DI code: 05404035100844
Reference / catalog number: 22162

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Manufacturer information

Organization name: Cypress Diagnostics
SRN: BE-MF-000000033
Manufacturer status: Active

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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.

Critical warnings

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

CW010
See IFU

Market distribution

Primary placement in Belgium; available across 1 country total.

Placed on the market in Belgium; per-country availability dates not published.

Device identification

Trade name: Waaler Rose
UDI-DI code: 05404035100844
Basic UDI-DI: B-05404035100844
Reference / catalog number: 22162
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The Waaler Rose test is a slide hemagglutination test, intended for the qualitative and semi-quantitative detection of Rheumatoid Factors in human serum. For in vitro diagnostic use only. For professional use only.
Additional information URL: https://www.diagnostics.be/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01021110RHEUMATOID FACTORS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Software identification