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Onco PanScan™ Gene Mutation Detection Kit

by Genetron Health (Beijing) Co., Ltd.

Ref RSN043, RSN041, RSN042

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975029660280 Basic UDI-DI Date20 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Trade Name
Onco PanScan™ Gene Mutation Detection Kit
Onco PanScanTM Gene Mutation Detection Kit
Model / Reference
RSN043, RSN041, RSN042
Primary DI / UDI-DI
06975029660280, 06975029660266, 06975029660396, 06975029660402
Basic UDI-DI
B-06975029660280, B-06975029660266, B-06975029660396, B-06975029660402
EMDN Code
W01060299 Tests for acquired genetic or chromosomal alterations - other
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000046433
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Genetron Health (Beijing) Co., Ltd.

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Properties

  • Reagent
  • Professional Testing
  • Companion Diagnostics

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Surgical Instrument: No
  • New Device: No