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Hemostasis Analyzer System

by Render Biotech Co., Ltd. China EUDAMED

Ref TE001Model IMTEG2

EMDN W0202029001

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697603340TE001CP Basic UDI-DIDate21 Jun 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
IMTEG2, TE001
Primary DI / UDI-DI
06976033400008
Basic UDI-DI
697603340TE001CP
EMDN Code
W0202029001 Thrombelastographs
Device Class
Class A
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000032470
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Render Biotech Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED 44a7c99c-5d94-4caa-910f-acbbb3398bee 61 fields · synced 22 Oct 2026