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LENTELL UroBag II XS +1 more model
EUDAMEDClass I (EU MDR)
Ref 201140-1Ref 201140
Identity
- Trade Name
- LENTELL UroBag II XS; Transparent EUDAMEDLENTELL UroBag II XS EUDAMED
- Device Name
- Ostomy Products EUDAMED
- Model / Reference
- 201140-1 EUDAMED201140 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858892211625 EUDAMED03858892211151 EUDAMED
- Basic UDI-DI
- 385889221stomaprodsSF EUDAMED
- EMDN Code
- A10020401 UROSTOMY BAGS FOR TWO-PART SYSTEMS, W/O TISSUE COVER EUDAMEDA10020402 UROSTOMY BAGS FOR TWO-PART SYSTEMS, WITH TISSUE COVER EUDAMED
- Models / Variants
- LENTELL UroBag II XS 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 UroBag II XS +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 |
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Manufacturer
- Manufacturer
- Lentismed d.o.o.
- EUDAMED SRN
- HR-MF-000018298
Sources (2)
- EUDAMED 5f14952f-50f9-44d0-9863-c629150aafed 61 fields · synced Jul 25, 2026
- EUDAMED dc88c4ab-0164-430a-a9ab-e384cb802bd5 61 fields · synced May 17, 2026