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TECal N

by TECO Medical Instruments, Production + Trading GmbH Germany EUDAMED

Ref P8001-005

EMDN W0103020701

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-CAL-P8001-005X8 Basic UDI-DIDate16 Aug 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Cal
Model / Reference
P8001-005
Primary DI / UDI-DI
D-CAL-P8001-005X8
Basic UDI-DI
B-CAL-P8001-005X8
EMDN Code
W0103020701 Calibration plasma for haemostasis
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000022642

Other devices from TECO Medical Instruments, Production + Trading GmbH

See all devices from TECO Medical Instruments, Production + Trading GmbH →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 87faefdd-4898-416d-b4ff-b32974362c67 61 fields · synced 22 Oct 2026