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Whole Blood DNA Extraction Kit (Magnetic Bead Method)

by Jiangsu Bioperfectus Technologies Co., Ltd. 3 variants

Ref SDK60110-48T(16*3)

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number697334200SDK60110APKPH Basic UDI-DI 06973342002589UDI-DIDate7 May 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06973342002589 UDI-DI Date2 Feb 2023ListedStatusListed 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  • Withdrawn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 / Reference
SDK60110-48T(16*3) EUDAMED
48 Tests (16*3) GUDID
Primary DI / UDI-DI
06973342002589
Basic UDI-DI
697334200SDK60110APKPH
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
SDK60110-48T(16*3)
GUDID
48 Tests (16*3)
Device ClassEUDAMED
Class A
GUDID
Class I

Manufacturer details

EUDAMED SRN
CN-MF-000014691
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Related devices

Category: Nucleic acid extraction/isolation kit IVD

Other devices from Jiangsu Bioperfectus Technologies Co., Ltd.

See all devices from Jiangsu Bioperfectus Technologies Co., Ltd. →

Properties

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

Other properties (15)

  • 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