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LENTELL ileobag II kids +1 more model
EUDAMEDClass I (EU MDR)
Ref 201112-1Ref 201112-1C
Identity
- Trade Name
- LENTELL ileobag II kids; transparent EUDAMEDLENTELL IleoBag II kids; transparent; clamp EUDAMED
- Device Name
- Ostomy Products EUDAMED
- Model / Reference
- 201112-1 EUDAMED201112-1C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858892214763 EUDAMED03858892215531 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 kids 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 kids +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 ff13cb86-33b8-4765-852b-a4d5793d99d0 61 fields · synced Jul 19, 2026
- EUDAMED 02ba6413-ae5a-4d1c-bfe5-f2f4630c5b8b 61 fields · synced May 18, 2026