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Organization name
UDI-DI code
Reference / catalog number

A48383 — IVDR Class A IVDR by Thermo Fisher…

MD Atlas
Thermo Fisher Scientific Baltics UAB

EUDAMED last updated this device on Mar 23, 2026

A48383

0190302MVP2TT

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Thermo Fisher Scientific Baltics UAB
UDI-DI code: 10190302018241
Reference / catalog number: A48383

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View device family (Basic UDI)

Manufacturer information

Organization name: Thermo Fisher Scientific Baltics UAB
SRN: LT-MF-000046574
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

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

CW085
Causes serious eye irritation
CW422
IF ON SKIN: Wash with plenty of soap and water
CW305
If skin irritation occurs: Get medical advice/attention
CW163
Do not eat, drink or smoke when using this product
CW999
P305 + P351 + P338 - IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing
CW076
Harmful if swallowed
CW081
Causes severe skin burns and eye damage
CW106
Harmful to aquatic life with long lasting effects
CW158
Do not breathe dust/fume/gas/mist/vapours/spray
CW162
Wash hands thoroughly after handling
CW166
Avoid release to the environment
CW167
Wear protective gloves/protective clothing/eye protection/face protection
CW296
IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell
CW999
P301 + P330 + P331 - IF SWALLOWED: Rinse mouth. Do NOT induce vomiting
CW999
P303 + P361 + P353 - IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower
CW401
IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing
CW999
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing
CW999
P330 - Rinse mouth
CW185
If experiencing respiratory symptoms: Call a POISON CENTER or doctor/physician
CW999
P310 - Immediately call a POISON CENTER or doctor/physician
CW999
P363 - Wash contaminated clothing before reuse
CW082
Causes skin irritation
CW304
If eye irritation persists: Get medical advice/attention
CW171
In case of inadequate ventilation wear respiratory protection
CW159
Avoid breathing dust/fume/gas/mist/vapours/spray
CW999
P362 + P364 - Take off contaminated clothing and wash it before reuse
CW089
May cause allergy or asthma symptoms or breathing difficulties if inhaled

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Market distribution

Primary placement in Austria; available across 1 country total.

Country	On market since	Until
AustriaPrimary placement	Nov 26, 2020	Still on market

Device identification

Trade name: not provided
UDI-DI code: 10190302018241
Basic UDI-DI: 0190302MVP2TT
Reference / catalog number: A48383
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The MagMAX™ Viral/Pathogen II Nucleic Acid Isolation Kit is a nucleic acid purification kit based on magnetic bead technology. The kit is intended for the isolation and purification of viral nucleic acids from human nasopharyngeal swabs and viral RNA from saliva specimens, and is suitable for use in molecular detection by qPCR. The kit is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of magnetic bead purification, either manual or automated, and in vitro diagnostic procedures.
Additional information URL: https://www.thermofisher.com/order/catalog/product/A48383
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)10190302018241

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W0105900101REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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