Identity
- Trade Name
- LENTELL flexi II L EUDAMED
- Device Name
- Ostomy Products EUDAMED
- Model / Reference
- 201120AB EUDAMED201120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858892216668 EUDAMED03858892214350 EUDAMED
- Basic UDI-DI
- 385889221stomaprodsSF EUDAMED
- EMDN Code
- A1002010401 UNIVERSAL PLATES FOR ABDOMINAL STOMA (COLO-, ILEO-, UROSTOMY) WITH NON-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 flexi II L 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 31cc46d1-6a81-453c-9ff1-3f3e346ffcd5 61 fields · synced Jul 10, 2026
- EUDAMED 1542c65e-7187-4ae0-b1b7-79d5cf3b5811 61 fields · synced May 17, 2026