Identity
- Trade Name
- LENTELL OstoZip II; small; transparent EUDAMED
- Device Name
- Ostomy Products EUDAMED
- Model / Reference
- 201118-1S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858892214916 EUDAMED
- Basic UDI-DI
- 385889221stomaprodsSF EUDAMED
- EMDN Code
- A100205 EXPANSION CAPS FOR TWO-PIECE ABDOMINAL OSTOMY SYSTEMS EUDAMED
- Models / Variants
- LENTELL OstoZip II EUDAMEDsmall 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 OstoZip II +2 more models by Lentismed d.o.o. — Class I — MDR — listed in EUDAMED — 3 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 (1)
- EUDAMED 1b6cd0ce-a734-490a-b707-d9b98d1de8a6 61 fields · synced Jun 18, 2026