Identity
- Trade Name
- LENTELL IleoBag II XL; transparent EUDAMED
- Device Name
- Ostomy Products EUDAMED
- Model / Reference
- 201158-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858892217955 EUDAMED
- Basic UDI-DI
- 385889221stomaprodsSF EUDAMED
- EMDN Code
- A10020301 ILEOSTOMY BAGS FOR TWO-PART SYSTEMS, W/O TISSUE COVER EUDAMED
- Models / Variants
- LENTELL IleoBag II XL EUDAMEDtransparent 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 XL +1 more model by Lentismed d.o.o. — Class I — MDR — listed in EUDAMED — 2 models — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lentismed d.o.o.
- EUDAMED SRN
- HR-MF-000018298
Sources (1)
- EUDAMED c252c18b-7c56-42d7-a55b-a3ac69d7885e 61 fields · synced Jun 19, 2026