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Electrolyte analyzer

EUDAMED

Class A (EU MDR)

Ref MINI ISERef K-Lite8DModel K-Lite8ARef AFT-500Model AFT-CRef AFT-800FModel AFT-800Ref AFT-800DRef K-Lite8FRef AFT-800GRef KLite-CRef AFT-800ARef K-Lite8ERef AFT-300Ref K-Lite3Ref K-Lite8HRef PR705Model AFT-800A、AFT-800B、AFT-800D、AFT-800E、AFT-800F、AFT-800G、AFT-800HModel K-Lite8A、K-Lite8B、K-Lite8D、K-Lite8E、K-Lite8F、K-Lite8G、K-Lite8H、K-Lite8Model AFT-300、AFT-400、AFT-500、PR703、PR705、K-Lite3、K-Lite5、PR-C、AFT-C、KLite-CRef /

by Meizhou Cornley Hi-Tech Co., Ltd.

Identity

Trade Name
cornley EUDAMED
Device Name
Electrolyte analyzer EUDAMED
Electrolytes Analyzer EUDAMED
Model / Reference
MINI ISE EUDAMED
K-Lite8A EUDAMED
K-Lite8D EUDAMED
AFT-C EUDAMED
AFT-500 EUDAMED
AFT-800 EUDAMED
AFT-800F EUDAMED
AFT-800D EUDAMED
K-Lite8F EUDAMED
AFT-800G EUDAMED
KLite-C EUDAMED
AFT-800A EUDAMED
K-Lite8E EUDAMED
AFT-300 EUDAMED
K-Lite3 EUDAMED
K-Lite8H EUDAMED
PR705 EUDAMED
AFT-800A、AFT-800B、AFT-800D、AFT-800E、AFT-800F、AFT-800G、AFT-800H EUDAMED
K-Lite8A、K-Lite8B、K-Lite8D、K-Lite8E、K-Lite8F、K-Lite8G、K-Lite8H、K-Lite8 EUDAMED
AFT-300、AFT-400、AFT-500、PR703、PR705、K-Lite3、K-Lite5、PR-C、AFT-C、KLite-C EUDAMED
/ EUDAMED

Identifiers

Primary DI / UDI-DI
06947929501277 EUDAMED
06947929500621 EUDAMED
06947929531144 EUDAMED
06947929500584 EUDAMED
06947929500560 EUDAMED
06947929500645 EUDAMED
06947929500591 EUDAMED
06947929599687 EUDAMED
06947929500546 EUDAMED
06947929500638 EUDAMED
06947929531137 EUDAMED
06947929500751 EUDAMED
06947929500669 EUDAMED
06947929588568 EUDAMED
06947929500850 EUDAMED
Basic UDI-DI
69479295MINI4M EUDAMED
69479295K-Lite5H EUDAMED
69479295AFT8R EUDAMED
69479295AFT-800TL EUDAMED
EMDN Code
W0201040102 BLOOD GAS ANALYSERS - WITH ADDITIONAL PARAMETERS (pH, pO2, pCO2, Hct + metabolites + electrolytes, CO-oximeter parameters and coagulation parameters) EUDAMED
W0201040201 ION SELECTIVE ELECTROLYTE ANALYSERS EUDAMED
W0201040101 BLOOD GAS ANALYSERS - WITH CLASSIC PROFILE (pH, pO2, pCO2, HCT + electrolytes) EUDAMED
W0201040101,W0201040102 EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

Yes

EUDAMEDEUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMEDEUDAMED

Surgical Instrument

Yes

EUDAMED

New Device

No

EUDAMED

Electrolyte analyzer by Meizhou Cornley Hi-Tech Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
Meizhou Cornley Hi-Tech Co., Ltd.
EUDAMED SRN
CN-MF-000025014
Authorised Representative
Caretechion GmbH DE-AR-000005946

Sources (30)

  • EUDAMED 9a681302-f81c-4d95-9a76-2dd7fef5972a 61 fields · synced Sep 18, 2026
  • EUDAMED 2a1944eb-477c-464e-978f-32cd0ef20670 61 fields · synced May 17, 2026
  • EUDAMED f0ef1e44-892d-4fb3-900f-8e5b35f94bb2 61 fields · synced May 17, 2026
  • EUDAMED 8b043e54-1394-48a9-a40e-522672ee4799 61 fields · synced May 18, 2026
  • EUDAMED 44ce1b50-2206-448a-bf4b-4c53123faec8 61 fields · synced May 18, 2026
  • EUDAMED beea9244-2de0-417c-b70c-0d66c7b83053 61 fields · synced May 18, 2026
  • EUDAMED 68540182-fece-4823-8c7c-d9b253b67bf9 61 fields · synced May 18, 2026
  • EUDAMED 2e9037d4-7a43-4f56-98d8-b55e44c1655b 61 fields · synced May 18, 2026
  • EUDAMED dc333d15-c82c-4f18-aa6e-cb4fecb7df82 61 fields · synced May 18, 2026
  • EUDAMED 37cafb44-5ed1-4d46-9f44-342172e9b20c 61 fields · synced May 18, 2026
  • EUDAMED 353e4841-a6f8-4a30-9757-760fbb668929 61 fields · synced May 18, 2026
  • EUDAMED 7f7ddaf4-2346-4be0-aa75-d12c36672423 61 fields · synced May 18, 2026
  • EUDAMED 4f68a7c4-c4ee-4173-ad69-dfaea5059e3d 61 fields · synced May 18, 2026
  • EUDAMED 0b722afc-b5c3-4cfd-add9-2db108697e23 61 fields · synced May 19, 2026
  • EUDAMED 5c70d14c-e0d3-42bb-8f7a-16fee12c8ff9 61 fields · synced May 19, 2026
  • EUDAMED e64691d4-9e62-43eb-888b-374bb85d8c02 61 fields · synced Jul 9, 2026
  • EUDAMED 23ceef62-f023-417d-9bba-817e59769891 61 fields · synced Jul 10, 2026
  • EUDAMED 634feb92-8a71-4c19-8a76-b315ae89a505 61 fields · synced Jul 11, 2026
  • EUDAMED 9329ed99-a278-4b86-98ce-0c1bb06b25e8 61 fields · synced Jul 13, 2026
  • EUDAMED 991c3764-435e-4c81-bcf9-fc9c2d2101b1 61 fields · synced Jul 13, 2026
  • EUDAMED 9123ea58-7fe6-4f08-b168-7a5f56906292 61 fields · synced Jul 14, 2026
  • EUDAMED a711565f-acec-4a4a-8ad8-21bb8d09fde3 61 fields · synced Jul 17, 2026
  • EUDAMED b99a0b7e-8541-41fb-9448-e18bb1b55ae1 61 fields · synced Jul 18, 2026
  • EUDAMED 51b8c3d3-3228-4d16-9378-a9929c25a54c 61 fields · synced Jul 24, 2026
  • EUDAMED 4ebfa6bd-17c0-4078-a428-49d9df507182 61 fields · synced Jul 27, 2026
  • EUDAMED 294b79ca-5ea7-4f02-9103-4c4ae612ecf6 61 fields · synced Jul 31, 2026
  • EUDAMED 774831a7-c992-4354-a3c0-516711d5a8b4 61 fields · synced Jul 31, 2026
  • EUDAMED 2930e184-15a9-4300-a32a-4afbd328291a 61 fields · synced Aug 4, 2026
  • EUDAMED dd081bfb-9b25-4bfd-86f7-9ca763eaff62 61 fields · synced Sep 18, 2026
  • EUDAMED bc18928e-8220-4adc-899b-d9c9a01138bd 61 fields · synced Sep 18, 2026