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Nucleic Acid Release Reagent

EUDAMED

Class A (EU MDR)

Ref PR01010N01T2050Ref P049T05501

by Jiangsu Mole Bioscience Co., LTD.

Identity

Device Name
Nucleic Acid Release Reagent EUDAMED
Model / Reference
PR01010N01T2050 EUDAMED
P049T05501 EUDAMED

Identifiers

Primary DI / UDI-DI
06970895471756 EUDAMED
06970895471947 EUDAMED
Basic UDI-DI
697089547NARR00UY EUDAMED
EMDN Code
W050299 DEVICES FOR SAMPLES TRANSPORT - OTHER EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Czechia 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: General specimen container IVD, no additive/medium

Nucleic Acid Release Reagent by Jiangsu Mole Bioscience Co., LTD. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as General specimen container IVD, no additive/medium.

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 (2)

  • EUDAMED 8dfca747-d656-43fa-8a81-22424d27942a 61 fields · synced Jul 31, 2026
  • EUDAMED 135709b6-4e01-4988-a284-e9f86c5b3e58 61 fields · synced May 19, 2026