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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
06970952648145 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
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 (2)

  • EUDAMED 6520b204-8720-4f59-a68b-c297be92d7f7-1 61 fields · synced Jun 19, 2026
  • EUDAMED 6520b204-8720-4f59-a68b-c297be92d7f7-2 61 fields · synced Jun 19, 2026