Identity
- Trade Name
- Irrigation Pump EUDAMED
- Device Name
- Irrigation Pump EUDAMED
- Model / Reference
- IP Series EUDAMEDIP-1000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04714123021939 EUDAMED
- Basic UDI-DI
- 471412302IP-01TH EUDAMED
- EMDN Code
- Z12019007 IRRIGATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Croatia EUDAMED
Clinical & Handling
Sterile
No
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
Category: Endoscopic spray catheter, single-use
Irrigation Pump by Lagis Enterprise Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 471412302IP-01TH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Lagis Enterprise Co., Ltd.
- EUDAMED SRN
- TW-MF-000007081
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 09d0f0bb-d911-4a54-aa40-8d7f2e400eff 61 fields · synced Jun 19, 2026