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Nucleic Acid Extraction System

by Jiangsu Bioperfectus Technologies Co., Ltd. 4 variants

Ref SSNP-9600AModel SSNP-2000B, SSSNP-3000A, SSNP-9600A,SMPE-960, SSNP-A6

Nucleic Acid Extraction System (SSNP-9600A) is a nucleic acid sample preparation instrument IVD (EU IVDR Class A; FDA Class I; FDA product code JJH, Clinical Sample Concentrator) made by Jiangsu Bioperfectus Technologies Co., Ltd., registered in EUDAMED on 7 May 2025 (Basic UDI-DI 697334200SSNPMP) and listed in FDA GUDID since 2 Feb 2023 (UDI-DI 06973342000219), active as of 22 Oct 2026.

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

CE IVDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number697334200SSNPMP Basic UDI-DI 06973342000219UDI-DIDate7 May 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06973342000219 UDI-DI Date2 Feb 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 697334200SSNPMP registered 7 May 2025 Active
  • FDA GUDID UDI-DI 06973342000219 listed 2 Feb 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 06973342000219
  2. Registered EUDAMED 697334200SSNPMP

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  • Withdrawn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 sample preparation instrument IVD
Model / reference
SSNP-2000B, SSSNP-3000A, SSNP-9600A, SMPE-960, SSNP-A6
Primary DI / UDI-DI
06973342000219
Basic UDI-DI
697334200SSNPMP
FDA product code
JJH
EMDN code
W02069099 Various sample processing instruments - other
GMDN term
Nucleic acid sample preparation instrument IVD
Device class
Class A EUDAMED
Class I GUDID
Regulation number
862.2310
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class A
GUDID
Class I

Device class is stated on each registry's own scale: Class A in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

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

Similar devices in this category

Other devices filed under VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER.

Other devices from Jiangsu Bioperfectus Technologies Co., Ltd.

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

Properties

  • Professional testing
  • IVD instrument
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)