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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

21001D — IVDD — General IVDD by Thermo Fisher…

MD Atlas
Thermo Fisher Scientific Baltics UAB

EUDAMED last updated this device on Mar 30, 2026

21001D

B-10190302006798

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Thermo Fisher Scientific Baltics UAB
UDI-DI code: 10190302006798
Reference / catalog number: 21001D

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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

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Lithuania; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 10190302006798
Basic UDI-DI: B-10190302006798
Reference / catalog number: 21001D
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: Dynabeads™ HLA Class I is designed for rapid isolation of CD8+T lymphocytes directly from peripheral blood. The isolated cells can be used directly in microcytotoxic HLA Class I (A, B, C) assays. Device is intended for professional use. The users are laboratories performing microcytotoxic assays: • Bone Marrow Registries • Donor Selection (solid organ & bone marrow) • Research Uses • Laboratories performing high throughput typing
Additional information URL: No additional information URL provided by the manufacturer.
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)10190302006798

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EMDN nomenclature code(s)

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

W01030405LYMPHOCYTE SEPARATION MEDIA

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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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.