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Lentell Convex II S extended wear time
EUDAMEDClass I (EU MDR)
Ref 201121ETRef 201121
Identity
- Trade Name
- Lentell Convex II S extended wear time EUDAMEDLENTELL convex II S EUDAMED
- Device Name
- Ostomy Products EUDAMED
- Model / Reference
- 201121ET EUDAMED201121 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858892219126 EUDAMED03858892214367 EUDAMED
- Basic UDI-DI
- 385889221stomaprodsSF EUDAMED
- EMDN Code
- A1002010402 UNIVERSAL PLATES FOR ABDOMINAL STOMA (COLO-, ILEO-, UROSTOMY) WITH INTROFLEX STOMA 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 Convex II S extended wear time by Lentismed d.o.o. — Class I — MDR — listed in EUDAMED — 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 80a7ec23-d810-4803-85cd-afc915fbc186 61 fields · synced Jul 20, 2026
- EUDAMED 19d69fe3-a601-4f4a-bf87-c8747b918334 61 fields · synced May 19, 2026