← Back to catalogue
LENTELL UroBag II XXS +1 more model
EUDAMEDClass I (EU MDR)
Ref 201166-1Ref 201166
Identity
- Trade Name
- LENTELL UroBag II XXS; transparent EUDAMEDLENTELL UroBag II XXS EUDAMED
- Device Name
- Ostomy Products EUDAMED
- Model / Reference
- 201166-1 EUDAMED201166 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858892217962 EUDAMED03858892217245 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 XXS 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 XXS +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 (2)
- EUDAMED 8167bee0-5b86-4880-8742-6e153ca957f8 61 fields · synced Aug 1, 2026
- EUDAMED bc25e9e5-2ba1-470f-ba25-2816b836280f 61 fields · synced May 19, 2026