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i-MIMERsys Irrigation and Suction Pump
EUDAMEDClass IIa (EU MDR)
Ref ZSR-ISP100
Identity
- Trade Name
- i-MIMERsys Irrigation and Suction Pump EUDAMED
- Device Name
- i-MIMERsys Irrigation and Suction Pump EUDAMED
- Model / Reference
- ZSR-ISP100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936345127611 EUDAMED
- Basic UDI-DI
- 69363451ZSRISP1009X EUDAMED
- Direct Marketing DI
- 06936345127611 EUDAMED
- EMDN Code
- Z120105,Z12019007 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
i-MIMERsys Irrigation and Suction Pump 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 | 69363451ZSRISP1009X | 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 (1)
- EUDAMED 560ab528-5339-49e0-a1c2-ec4bb9a8f98c 61 fields · synced Jun 18, 2026