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Plastic pipette(Plastic dropper/Plastic capillary tube)

EUDAMED

Class A (EU MDR)

Ref N/AModel 10μL,15μL,20μL,25μL,30μL,35μL,40μL,50μL,60μL,80μL,100μL,120μL,1ml,2ml,3ml, 5ml, 10ml/Single bulb, double bulb, fill line

by Jiangsu Kehua Medical Instrument Technology Co., Ltd.

Identity

Device Name
Plastic pipette(Plastic dropper/Plastic capillary tube) EUDAMED
Model / Reference
10μL,15μL,20μL,25μL,30μL,35μL,40μL,50μL,60μL,80μL,100μL,120μL,1ml,2ml,3ml, 5ml, 10ml/Single bulb, double bulb, fill line EUDAMED
N/A EUDAMED

Identifiers

Primary DI / UDI-DI
06970952640163 EUDAMED
Basic UDI-DI
697095264PP001KL EUDAMED
EMDN Code
W050302010102 SEROLOGICAL AND DILUTION PIPETTES, PLASTIC EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Bulgaria 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

Yes

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Plastic pipette(Plastic dropper/Plastic capillary tube) by Jiangsu Kehua Medical Instrument Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

EUDAMED SRN
CN-MF-000028654
Authorised Representative
Sungo Cert GmbH DE-AR-000010869

Sources (2)

  • EUDAMED 08158f74-9bdc-495c-aec9-9129faa344c4 61 fields · synced Jun 18, 2026
  • EUDAMED 08158f74-9bdc-495c-aec9-9129faa344c4-1 61 fields · synced Jun 10, 2026