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POCT ampule

EUDAMED

Class A (EU MDR)

Ref N/AModel 50μL,60μL,70-2000μL

by Jiangsu Kehua Medical Instrument Technology Co., Ltd.

Identity

Device Name
POCT ampule EUDAMED
Model / Reference
50μL,60μL,70-2000μL EUDAMED
N/A EUDAMED

Identifiers

Primary DI / UDI-DI
06970952648015 EUDAMED
06970952648060 EUDAMED
06970952648138 EUDAMED
06970952648121 EUDAMED
06970952648107 EUDAMED
06970952648084 EUDAMED
06970952648053 EUDAMED
06970952648046 EUDAMED
06970952648176 EUDAMED
06970952648152 EUDAMED
Basic UDI-DI
697095264POCTA001EP EUDAMED
EMDN Code
W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Bulgaria EUDAMED
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

No

EUDAMED

Professional Testing

No

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

POCT ampule by Jiangsu Kehua Medical Instrument Technology 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
Jiangsu Kehua Medical Instrument Technology Co., Ltd.
EUDAMED SRN
CN-MF-000028654
Authorised Representative
Sungo Cert GmbH DE-AR-000010869

Sources (20)

  • EUDAMED 2d5241c8-9a1b-4b98-a4f4-6bb5fe114b93 61 fields · synced Oct 6, 2026
  • EUDAMED 2d5241c8-9a1b-4b98-a4f4-6bb5fe114b93-1 61 fields · synced Jun 9, 2026
  • EUDAMED 350db02d-3f4d-419e-8215-d4e526df2585-1 61 fields · synced Jul 12, 2026
  • EUDAMED 350db02d-3f4d-419e-8215-d4e526df2585-2 61 fields · synced Jul 12, 2026
  • EUDAMED 3ce64cf7-0a06-4157-95ee-7009592967d6-1 61 fields · synced Jul 14, 2026
  • EUDAMED 3ce64cf7-0a06-4157-95ee-7009592967d6-2 61 fields · synced Jul 14, 2026
  • EUDAMED f44a92b8-05eb-4838-8d38-845b623ea398-1 61 fields · synced Jul 14, 2026
  • EUDAMED f44a92b8-05eb-4838-8d38-845b623ea398-2 61 fields · synced Jul 14, 2026
  • EUDAMED a0007fe9-37a4-4dde-85df-39d008d6f21b-1 61 fields · synced Jul 17, 2026
  • EUDAMED a0007fe9-37a4-4dde-85df-39d008d6f21b-2 61 fields · synced Jul 17, 2026
  • EUDAMED 47c0b7ea-308e-439d-bbfb-26ec2cd5f5a7-1 61 fields · synced Jul 21, 2026
  • EUDAMED 47c0b7ea-308e-439d-bbfb-26ec2cd5f5a7-2 61 fields · synced Jul 21, 2026
  • EUDAMED 1c1b9463-f6df-4c39-bbe9-e370b1e1dbe7-1 61 fields · synced Jul 29, 2026
  • EUDAMED 1c1b9463-f6df-4c39-bbe9-e370b1e1dbe7-2 61 fields · synced Jul 29, 2026
  • EUDAMED 19817430-c519-46f7-a052-3ada9bc28a76-1 61 fields · synced Jul 30, 2026
  • EUDAMED 19817430-c519-46f7-a052-3ada9bc28a76-2 61 fields · synced Jul 30, 2026
  • EUDAMED 3fd5b5c9-b988-4e2f-80d6-8813f58ed8c2-1 61 fields · synced Jul 31, 2026
  • EUDAMED 3fd5b5c9-b988-4e2f-80d6-8813f58ed8c2-2 61 fields · synced Jul 31, 2026
  • EUDAMED 2156edf2-1c55-49ca-b93d-162403071fa5-1 61 fields · synced Sep 18, 2026
  • EUDAMED 2156edf2-1c55-49ca-b93d-162403071fa5-2 61 fields · synced Sep 18, 2026