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Nucleic Acid Extraction Kit (Spin Column)

EUDAMED

Class A (EU MDR)

Ref P08201T2100Ref P08203P2050Ref P08205T2050Ref P08202T2024 Ref P08202T2050

by Jiangsu Mole Bioscience Co., LTD.

Identity

Device Name
Nucleic Acid Extraction Kit (Spin Column) EUDAMED
Model / Reference
P08201T2100 EUDAMED
P08203P2050 EUDAMED
P08205T2050 EUDAMED
P08202T2024 EUDAMED
P08202T2050 EUDAMED

Identifiers

Primary DI / UDI-DI
06970895477482 EUDAMED
06970895472661 EUDAMED
06970895472906 EUDAMED
06970895477987 EUDAMED
06970895473118 EUDAMED
Basic UDI-DI
697089547NAEK01R4 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
Romania 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

Nucleic Acid Extraction Kit (Spin Column) by Jiangsu Mole Bioscience 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

Manufacturer
Jiangsu Mole Bioscience Co., LTD.
EUDAMED SRN
CN-MF-000001539
Authorised Representative
Lotus NL B.V. NL-AR-000000121

Sources (5)

  • EUDAMED 0e0bdca4-54a9-43ff-b307-bcffef5af519 61 fields · synced Oct 1, 2026
  • EUDAMED a7f7bf79-47de-46b4-85ff-60b7380115e3 61 fields · synced May 16, 2026
  • EUDAMED 596b8f33-7f69-460b-abe1-a094b6bd6c43 61 fields · synced May 16, 2026
  • EUDAMED ccb3f589-40b9-4882-9400-78dfb53f15a5 61 fields · synced May 17, 2026
  • EUDAMED 65040bde-99be-4d64-ab7e-d881903501cf 61 fields · synced May 18, 2026