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STARMag™ M96 Kit

by Seegene, Inc.

Ref EX00030P

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number924000EX00029G2 Basic UDI-DI 08809240000298UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809240000298 UDI-DI Date5 Dec 2025ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Nucleic acid extraction/isolation kit IVD
Model / Ref / Catalog
EX00030P, 1
Primary DI / UDI-DI
08809240000298
Basic UDI-DI
924000EX00029G2
FDA Product Code
JJH
EMDN Code
W0105900101 Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus
GMDN Term
Nucleic acid extraction/isolation kit IVD
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
862.2310
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
EX00030P
GUDID
1
Device ClassEUDAMED
Class A
GUDID
Class I

Manufacturer details

EUDAMED SRN
KR-MF-000022275
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Seegene Inc.

See all devices from Seegene Inc. →

Properties

  • Reagent
  • Professional Testing
  • Prescription Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (16)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No