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Intact Parathyroid Hormone Chemiluminescence Immunoassay Kit

by Nanjing RealMind Biotech Co., Ltd.

Ref 50tests/kit, 100tests/kit, 215D00001Model Reagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )50tests/kit, Reagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )100tests/kit, Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle )50tests/kit, Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle): 100tests/kit, Reagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle )50tests/kit, Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle )100tests/kit, Reagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle ) 50tests/kit, Reagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle ) 100tests/kit

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-06972719603800 Basic UDI-DI Date22 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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Device Name
Intact Parathyroid Hormone Chemiluminescence Immunoassay Kit
Parathyroid Hormone Chemiluminescence Immunoassay Kit
Model / Reference
Reagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )50tests/kit, 50tests/kit, Reagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )100tests/kit, 100tests/kit, Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle )50tests/kit, Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle): 100tests/kit, 215D00001, Reagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle )50tests/kit, Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle )100tests/kit, Reagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle ) 50tests/kit, Reagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle ) 100tests/kit
Primary DI / UDI-DI
06972719603800, 06972719603787, 06972719604197, 06972719600595, 06972719603794, 06972719604180, 06972719605910, 06972719606863, 06972719606856, 06972719605903, 06972719606832, 06972719606849
Basic UDI-DI
B-06972719603800, B-06972719603787, B-06972719604197, B-06972719600595, B-06972719603794, B-06972719604180, B-06972719605910, B-06972719606863, B-06972719606856, B-06972719605903, B-06972719606832, B-06972719606849
EMDN Code
W0102060312, W0102060313
Device Class
Class IVD General
EU market of registration
Hungary

Manufacturer details

EUDAMED SRN
CN-MF-000024838
Authorised representative
Lotus NL B.V. NL-AR-000000121

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Properties

  • Reagent

Other properties (9)

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