Identity
- Trade Name
- LENTELL IleoBag II L EUDAMEDLENTELL ileobag II L; transparent EUDAMED
- Device Name
- Ostomy Products EUDAMED
- Model / Reference
- 201111F EUDAMED201111-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858892211731 EUDAMED03858892214756 EUDAMED
- Basic UDI-DI
- 385889221stomaprodsSF EUDAMED
- EMDN Code
- A10020302 ILEOSTOMY BAGS FOR TWO-PART SYSTEMS, WITH TISSUE COVER EUDAMEDA10020301 ILEOSTOMY BAGS FOR TWO-PART SYSTEMS, W/O TISSUE COVER EUDAMED
Classification
- Device Class
- Class I 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
LENTELL IleoBag II L by Lentismed d.o.o. — 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 | 385889221stomaprodsSF | Class I | Active |
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Manufacturer
- Manufacturer
- Lentismed d.o.o.
- EUDAMED SRN
- HR-MF-000018298
Sources (2)
- EUDAMED e3027fd1-98f8-44bb-9112-9c4abbf11cad 61 fields · synced Aug 1, 2026
- EUDAMED 9b135379-4487-4e0d-b0e1-4e2e27568481 61 fields · synced May 18, 2026