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Nucleic Acid Extraction Kit

EUDAMED

Class A (EU MDR)

Ref ZD001

by Biobase Diagnostic Technology (Shandong) Co., Ltd.

Identity

Trade Name
Nucleic Acid Extraction Kit EUDAMED
Device Name
Nucleic Acid Extraction Kit EUDAMED
Model / Reference
ZD001 EUDAMED

Identifiers

Primary DI / UDI-DI
06974969980670 EUDAMED
06974969980632 EUDAMED
06974969980731 EUDAMED
06974969980809 EUDAMED
06974969980601 EUDAMED
06974969980687 EUDAMED
06974969980748 EUDAMED
06974969980830 EUDAMED
06974969980595 EUDAMED
06974969980786 EUDAMED
06974969980618 EUDAMED
06974969980823 EUDAMED
06974969980755 EUDAMED
06974969980656 EUDAMED
06974969980793 EUDAMED
06974969983374 EUDAMED
06974969983442 EUDAMED
06974969983367 EUDAMED
06974969983459 EUDAMED
06974969983381 EUDAMED
06974969983435 EUDAMED
Basic UDI-DI
697496998ZD001YD EUDAMED
EMDN Code
W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS 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

Category: Nucleic acid extraction/isolation kit IVD

Nucleic Acid Extraction Kit by Biobase Diagnostic Technology (Shandong) Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Nucleic acid extraction/isolation kit IVD.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
Biobase Diagnostic Technology (Shandong) Co., Ltd.
EUDAMED SRN
CN-MF-000025964
Authorised Representative
Luxus Lebenswelt GmbH DE-AR-000005110

Sources (21)

  • EUDAMED 1ccef6ba-d11c-4f50-ba85-35a33f843067 61 fields · synced Oct 5, 2026
  • EUDAMED aa5cc6c3-42bd-4593-9fdd-0ece0b031705 61 fields · synced May 11, 2026
  • EUDAMED 625906a6-8022-47bf-9abd-de6415c70656 61 fields · synced May 16, 2026
  • EUDAMED d7e05cac-e659-4a90-ad81-4ab75c2a3a02 61 fields · synced May 16, 2026
  • EUDAMED 1d92bac6-eb6a-405e-a43a-790453642d24 61 fields · synced May 16, 2026
  • EUDAMED c2c0a4e6-1cdb-457f-9b25-527e37066ff9 61 fields · synced May 16, 2026
  • EUDAMED e92babb1-3fe1-462f-903f-c95331518bc3 61 fields · synced May 17, 2026
  • EUDAMED 5cc1e8c7-a7e0-4015-bd87-123aab0a3fcf 61 fields · synced May 18, 2026
  • EUDAMED 7e6b8ecc-1ca2-4bd4-9858-c8f6bbbbd0c2 61 fields · synced May 19, 2026
  • EUDAMED 9c8a4f33-48a4-453e-81d3-0318c1956c55 61 fields · synced May 19, 2026
  • EUDAMED f14e0f06-b950-4186-897c-69af0c5776ef 61 fields · synced May 19, 2026
  • EUDAMED c1e40b2a-022e-4522-9836-d77187455334 61 fields · synced May 19, 2026
  • EUDAMED 9ed75286-0aba-458b-9503-425043d94386 61 fields · synced May 19, 2026
  • EUDAMED aa8b47b0-10a2-4f17-8f83-0873168952da 61 fields · synced May 19, 2026
  • EUDAMED 14d38dfa-a802-405b-99b2-02ad6ddcae30 61 fields · synced May 19, 2026
  • EUDAMED 69bbcd4d-52fc-4f8a-b7bd-100fad94f38d 61 fields · synced Jun 20, 2026
  • EUDAMED c97a101c-3f3f-44e7-8e71-eb8526ac0135 61 fields · synced Jul 14, 2026
  • EUDAMED c1dac70c-d338-4965-895b-bc3e8c3a2bc0 61 fields · synced Jul 16, 2026
  • EUDAMED 98066157-943f-4dfe-852c-57afe30ac51a 61 fields · synced Jul 20, 2026
  • EUDAMED b23a335e-15e2-4ee7-84dc-1e4c5ac8eb7b 61 fields · synced Sep 17, 2026
  • EUDAMED 019fecbf-bcbc-4d09-9779-59cd764e21a4 61 fields · synced Oct 5, 2026