← Back to catalogue
LENTELL Basic II XS with adhesive boarder
EUDAMEDClass I (EU MDR)
Ref 201143ABRef 201143
Identity
- Trade Name
- LENTELL Basic II XS with adhesive boarder EUDAMEDLENTELL Basic II XS EUDAMED
- Device Name
- Ostomy Products EUDAMED
- Model / Reference
- 201143AB EUDAMED201143 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858892211663 EUDAMED03858892211656 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 Basic II XS with adhesive boarder 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 |
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 0d28aeb5-4b6e-4ad5-887e-37ea8d7b9e7a 61 fields · synced Jul 29, 2026
- EUDAMED 77edf705-2fe4-4487-87e2-ca7a450ff656 61 fields · synced May 17, 2026