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Dynabeads
EUDAMEDClass IVD General (EU MDR)
Ref 21004DModel Dynabeads HLA Class IIRef 21002DModel Dynabeads HLA Class I
Identity
- Trade Name
- Dynabeads EUDAMED
- Device Name
- In vitro diagnostic reagent designed for B lymphocytes immunomagnetic separation from peripheral blood EUDAMEDIn vitro diagnostic reagent designed for T lymphocytes immunomagnetic separation from peripheral blood EUDAMED
- Model / Reference
- Dynabeads HLA Class II EUDAMED21004D EUDAMEDDynabeads HLA Class I EUDAMED21002D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10190302006828 EUDAMED10190302006804 EUDAMED
- Basic UDI-DI
- B-10190302006828 EUDAMEDB-10190302006804 EUDAMED
- EMDN Code
- W01030405 LYMPHOCYTE SEPARATION MEDIA EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Lithuania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Dynabeads by Thermo Fisher Scientific Baltics UAB — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-10190302006828 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Thermo Fisher Scientific Baltics UAB
- EUDAMED SRN
- LT-MF-000046574
Sources (2)
- EUDAMED e2777426-2f5a-4e80-a73d-3b97f70197c7 61 fields · synced Jul 29, 2026
- EUDAMED 0b67addd-6c5f-4de3-8453-6fff6ea1b6b1 61 fields · synced May 17, 2026