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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 AAAC Plus Extraction… — IVDD — Annex II List B IVDD

MD Atlas
Labsystems Diagnostics Oy

EUDAMED last updated this device on Jul 23, 2024

NeoMass AAAC Plus Extraction Solution B

B-06438172403086

On the marketIVDD — Annex II List B

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Labsystems Diagnostics Oy
UDI-DI code: 06438172403086
Reference / catalog number: 710011009

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Manufacturer information

Organization name: Labsystems Diagnostics Oy
SRN: FI-MF-000018281
Manufacturer status: Active

Critical warnings

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

CW057
Highly Flammable
CW075
Toxic if swallowed
CW079
Toxic to skin
CW087
Toxic if inhaled
CW099
Causes damage to organs

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 AAAC Plus Extraction Solution B
UDI-DI code: 06438172403086
Basic UDI-DI: B-06438172403086
Reference / catalog number: 710011009
Issuing entity: GS1

Classification

Risk category: IVDD — Annex II List B
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 AAAC Plus Extraction Solution B serves as a reagent to extract the analytes present in DBS. it is also a component of Neomass AAAC plus 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)

W01010499MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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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.