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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

NeoMass CAH System Suitability… — IVDD — General IVDD

MD Atlas
Labsystems Diagnostics Oy

EUDAMED last updated this device on Aug 5, 2024

NeoMass CAH System Suitability Mixture (lyophilized)

B-06438172401129

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Labsystems Diagnostics Oy
UDI-DI code: 06438172401129
Reference / catalog number: 3467709

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Manufacturer information

Organization name: Labsystems Diagnostics Oy
SRN: FI-MF-000018281
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

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

CW102
may cause damage to organs
CW095
May cause cancer
CW096
May cause fertility issues in unborn child
CW097
May cause damage in fertility
CW098
May cause harm to breast fed child

Market distribution

Primary placement in Finland; available across 1 country total.

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

Device identification

Trade name: NeoMass CAH System Suitability Mixture (lyophilized)
UDI-DI code: 06438172401129
Basic UDI-DI: B-06438172401129
Reference / catalog number: 3467709
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: NeoMass CAH System Suitability Mixture (lyophilized) evaluates the performance of the column and the system's instrumental components. it is also a component of Neomass CAH kit for newborn screening
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0102152202HORMONE STANDARDS AND CALIBRATORS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Software identification