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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, 100 tests — IVDD — General IVDD

MD Atlas
Chronolab Systems, S.L.

EUDAMED last updated this device on Oct 13, 2025

Waaler Rose, 100 tests

B-084360385665660HK

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Chronolab Systems, S.L.
UDI-DI code: D-084360385665660HK
Reference / catalog number: 101-0219

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Manufacturer information

Organization name: Chronolab Systems, S.L.
SRN: ES-MF-000017043
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

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

CW011
R: H317 - May cause an allergic skin reaction. Contains 2- Methylisothiazol-3(2H)-one (Proclin 950). Control + / - : H317-May cause an allergic skin reaction. Contain 2- Methylisothiazol-3(2H)-one (Proclin 950). Follow the precautionary statements given in MSDS and label of the product.
CW008
Components from human origin have been tested and found to be negative for the presence of HBsAg, HCV, and antibody to HIV (1/2). However, handle cautiously as potentially infectious.

Market distribution

Primary placement in Spain; available across 1 country total.

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

Device identification

Trade name: Waaler Rose, 100 tests
UDI-DI code: D-084360385665660HK
Basic UDI-DI: B-084360385665660HK
Reference / catalog number: 101-0219
Issuing entity: EUDAMED

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: Kit content: Waaler Rose, Positive control, negative control All the kit components are ready to use. Additional equipment needed: Standard laboratory equipment.
Additional information URL: No additional information URL provided by the manufacturer.
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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