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i-MIMERsys Irrigation and Suction Pump (Disposable IRP Sheath)
EUDAMEDClass IIa (EU MDR)
Ref CYG1440Ref CYG1050Ref CYG1350Ref CYG1240Ref CYG0940Ref CYG1150Ref CYG1450Ref CYG1040
Identity
- Trade Name
- i-MIMERsys Irrigation and Suction Pump (Disposable IRP Sheath) EUDAMEDi-MIMERsys Irrigation and Suction Pump(Disposable IRP Sheath) EUDAMED
- Device Name
- i-MIMERsys Irrigation and Suction Pump(Disposable IRP Sheath) EUDAMEDi-MIMERsys Irrigation and Suction Pump (Disposable IRP Sheath) EUDAMED
- Model / Reference
- CYG1440 EUDAMEDCYG1050 EUDAMEDCYG1350 EUDAMEDCYG1240 EUDAMEDCYG0940 EUDAMEDCYG1150 EUDAMEDCYG1450 EUDAMEDCYG1040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936345117513 EUDAMED06936345117445 EUDAMED06936345117506 EUDAMED06936345117476 EUDAMED06936345117414 EUDAMED06936345117469 EUDAMED06936345117520 EUDAMED06936345117438 EUDAMED
- Basic UDI-DI
- 69363451ZSRCYG1440U4 EUDAMED69363451ZSRCYG1050TK EUDAMED69363451ZSRCYG1350U2 EUDAMED69363451ZSRCYG1240TS EUDAMED69363451ZSRCYG0940UN EUDAMED69363451ZSRCYG1150TQ EUDAMED69363451ZSRCYG1450U7 EUDAMED69363451ZSRCYG1040TG 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69363451ZSRCYG1440U4 | Class IIa | Active |
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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 (8)
- EUDAMED 37f0f75c-ecf0-4bd9-9c53-7551a5444865 61 fields · synced Oct 6, 2026
- EUDAMED 260830ad-cf0a-48e5-956d-6c439db7ee3a 61 fields · synced May 17, 2026
- EUDAMED 38ed9cae-c066-40d6-a5f9-2f903c35599b 61 fields · synced May 17, 2026
- EUDAMED a4bfa908-138e-4c3c-b208-3eb8ed1b11f4 61 fields · synced May 18, 2026
- EUDAMED df7c54c2-4416-4836-adc7-04ce519b8e03 61 fields · synced May 18, 2026
- EUDAMED ec4ebf0f-ed72-40e9-a73a-36917a1f475c 61 fields · synced May 18, 2026
- EUDAMED 20205dfe-905a-4931-b57b-3bc8501a35e8 61 fields · synced May 19, 2026
- EUDAMED d874ce43-513d-4e29-b802-a7dddccfc9b4 61 fields · synced May 19, 2026