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Respiratory Virus Transport Medium

EUDAMED

Class A (EU MDR)

Ref 20preps/boxRef 200preps/bag

by Genfine Biotech(changzhou) Co., Ltd

Identity

Device Name
Respiratory Virus Transport Medium EUDAMED
Model / Reference
20preps/box EUDAMED
200preps/bag EUDAMED

Identifiers

Primary DI / UDI-DI
06974898111060 EUDAMED
06974898111107 EUDAMED
Basic UDI-DI
697489811000006ZE EUDAMED
Direct Marketing DI
06974898111060 EUDAMED
06974898111107 EUDAMED
EMDN Code
A1102 SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM 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

No

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-purpose absorbent tip applicator/swab, single-use

Respiratory Virus Transport Medium by Genfine Biotech(changzhou) Co., Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose absorbent tip applicator/swab, single-use.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

EUDAMED SRN
CN-MF-000003399
Authorised Representative
MedPath GmbH DE-AR-000000087

Sources (2)

  • EUDAMED 04e4e3a3-f645-4beb-ac96-82c6b231ad08 61 fields · synced Aug 1, 2026
  • EUDAMED a95b3c3e-7f2b-4a6e-941a-144d195945df 61 fields · synced May 18, 2026