← Back to catalogue

Mumps Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

EUDAMED

Class IVD General (EU MDR)

Ref S3244E-48Ref S3279E-48Ref S3279E-24

by Sansure Biotech Inc.

Identity

Trade Name
Mumps Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
Device Name
Mumps Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
Masern virus, Rubella virus, and Mumps virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
Model / Reference
S3244E-48 EUDAMED
S3279E-48 EUDAMED
S3279E-24 EUDAMED

Identifiers

Primary DI / UDI-DI
06955792734203 EUDAMED
06955792735736 EUDAMED
06955792735729 EUDAMED
Basic UDI-DI
B-06955792734203 EUDAMED
B-06955792735736 EUDAMED
B-06955792735729 EUDAMED
EMDN Code
W0105040899 MUMPS / PAROTITIS VIRUS REAGENTS - OTHER EUDAMED
W0105070302 OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
France EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

Yes

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

Mumps Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) by Sansure Biotech Inc. — Class IVD General — IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Sansure Biotech Inc.
EUDAMED SRN
CN-MF-000011392
Authorised Representative
Obelis s.a. BE-AR-000000106

Sources (3)

  • EUDAMED 4dc340d2-6f53-4b71-927d-1a75ab1f7f5e 61 fields · synced Jul 19, 2026
  • EUDAMED 38cc7bb5-726f-4b62-b917-fb49d64d4c8d 61 fields · synced May 18, 2026
  • EUDAMED a01028a5-d2fd-40d3-ab56-ad9c5eb2bb57 61 fields · synced May 18, 2026