Identity
- Trade Name
- ENTEROCLISMA CONTENITORE 2.000 ml EUDAMED
- Device Name
- Enteroclisma EUDAMED
- Model / Reference
- 3088 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055510560720 EUDAMED
- Basic UDI-DI
- 805551056enteroclismaEM EUDAMED
- EMDN Code
- V9002 ENTEROCLYSIS DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
ENTEROCLISMA CONTENITORE 2.000 ml by Kaltek S.r.l. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 805551056enteroclismaEM | Class I | Active |
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Manufacturer
- Manufacturer
- Kaltek S.r.l.
- EUDAMED SRN
- IT-MF-000019573
Sources (1)
- EUDAMED bd196091-0f0d-4c42-98b1-cc033cdf81cd 61 fields · synced Jun 20, 2026