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i-MIMERsys Irrigation and Suction Pump (Disposable IRP Sheath)

EUDAMED

Class IIa (EU MDR)

Ref CYG1340

by Dongguan ZSR Biomedical Technology Company Limited

Identity

Trade Name
i-MIMERsys Irrigation and Suction Pump (Disposable IRP Sheath) EUDAMED
Device Name
i-MIMERsys Irrigation and Suction Pump(Disposable IRP Sheath) EUDAMED
Model / Reference
CYG1340 EUDAMED

Identifiers

Primary DI / UDI-DI
06936345117490 EUDAMED
Basic UDI-DI
69363451ZSRCYG1340TX EUDAMED
EMDN Code
K01020110 MINIMALLY INVASIVE SURGERY CANNULAS, SINGLE-USE EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Sweden EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

i-MIMERsys Irrigation and Suction Pump (Disposable IRP Sheath) by Dongguan ZSR Biomedical Technology Company Limited — Class IIa — MDR — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Dongguan ZSR Biomedical Technology Company Limited
EUDAMED SRN
CN-MF-000016828
Authorised Representative
Caretechion GmbH DE-AR-000005946

Sources (1)

  • EUDAMED f3a28e3e-5f5a-49af-873a-8e859e5b62ef 61 fields · synced Jun 18, 2026