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Sample Diluent

by Nanjing RealMind Biotech Co., Ltd. 5 variants

Ref D007 1x35mL/kit, D006 1x20mL/kit, D007 2x20mL/kit, D001 1x20mL/kit, D003 1x20mL/kit, D005 1x20mL/kit, D009 2x20mL/kit, D008 1x20mL/kit, D007 1x20mL/kit, D009 1x20mL/kit, D004 1x20mL/kit, D009 1x35mL/bottleModel Model: D001,D002,D003,D004,D005,D006,D007,D008,D009,D010,D011,D012

Active European Union

CE IVDR

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/IVDR Number6972719600003AT Basic UDI-DI Date26 May 2025RegisteredStatusActive

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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Device Name
Sample Diluent
Model / Reference
Model: D001, D002, D003, D004, D005, D006, D007, D008, D009, D010, D011, D012, D007 1x35mL/kit, D006 1x20mL/kit, D007 2x20mL/kit, D001 1x20mL/kit, D003 1x20mL/kit, D005 1x20mL/kit, D009 2x20mL/kit, D008 1x20mL/kit, D007 1x20mL/kit, D009 1x20mL/kit, D004 1x20mL/kit, D009 1x35mL/bottle
Primary DI / UDI-DI
06972719603558, 06972719600540, 06972719603541, 06972719600427, 06972719600519, 06972719600533, 06972719603565, 06972719600564, 06972719600557, 06972719601578, 06972719600526, 06972719601592
Basic UDI-DI
6972719600003AT
EMDN Code
W0599 IVD general use consumable devices - other
Device Class
Class A
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000024838
Authorised representative
Sungo Cert GmbH DE-AR-000010869

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Properties

  • Professional Testing

Other properties (10)

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