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Sample Diluent

EUDAMED

Class A (EU MDR)

Ref PO-0028-02Model PTD-A 400μL×50Ref W0103010105Ref PO-0027-02Ref 12.02.0805AModel PTD-A 25 bottle/bagRef 12.02.0802A

by Shenzhen Dymind Biotechnology Co., Ltd.

Identity

Trade Name
Sample Diluent EUDAMED
Device Name
Sample Diluent EUDAMED
Model / Reference
PTD-A 400μL×50 EUDAMED
PO-0028-02 EUDAMED
W0103010105 EUDAMED
PO-0027-02 EUDAMED
PTD-A 25 bottle/bag EUDAMED
12.02.0805A EUDAMED
12.02.0802A EUDAMED

Identifiers

Primary DI / UDI-DI
06976117453388 EUDAMED
06976117453340 EUDAMED
06976117453371 EUDAMED
06976117453272 EUDAMED
06941377300543 EUDAMED
Basic UDI-DI
6970493090801018PE EUDAMED
Direct Marketing DI
06976117453388 EUDAMED
06976117453340 EUDAMED
06976117453371 EUDAMED
06976117453272 EUDAMED
06941377300543 EUDAMED
EMDN Code
W0103010105 CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEATH-FLUIDS) EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

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

New Device

No

EUDAMED

Sample Diluent by Shenzhen Dymind Biotechnology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

EUDAMED SRN
CN-MF-000024842
Authorised Representative
Eunitor GmbH DE-AR-000005081

Sources (6)

  • EUDAMED 73bc024b-479a-4fc0-a8b9-07a11e040ea6 61 fields · synced Oct 6, 2026
  • EUDAMED 8303d4f3-db70-4de5-ac32-0d355d4bf1ac 61 fields · synced May 18, 2026
  • EUDAMED 54b24589-d6ae-45cd-b145-d743d6487c02 61 fields · synced May 18, 2026
  • EUDAMED f37a7873-b571-47bd-9fe4-d6fdc63f3a1a 61 fields · synced Jul 8, 2026
  • EUDAMED 1f2289bf-aca6-4298-b0c0-387e1380b470 61 fields · synced Jul 9, 2026
  • EUDAMED c496fdd4-8bb2-4ef5-a3a5-399d95164261 61 fields · synced Jul 9, 2026