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Dynabeads
EUDAMEDClass IVD General (EU MDR)
Ref 21003Model Dynabeads HLA Class II
Identity
- Trade Name
- Dynabeads EUDAMED
- Device Name
- In vitro diagnostic reagent designed for B lymphocytes immunomagnetic separation from peripheral blood EUDAMED
- Model / Reference
- Dynabeads HLA Class II EUDAMED21003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10190302006811 EUDAMED
- Basic UDI-DI
- B-10190302006811 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-10190302006811 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Thermo Fisher Scientific Baltics UAB
- EUDAMED SRN
- LT-MF-000046574
Sources (1)
- EUDAMED 97967224-cc5e-44a0-81ca-15a60d20138b 61 fields · synced May 29, 2026