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LENTELL Convex II L / pre-cut 38mm
EUDAMEDClass I (EU MDR)
Ref 201122PC-38Ref 201122
Identity
- Trade Name
- LENTELL Convex II L / pre-cut 38mm EUDAMEDLENTELL convex II L EUDAMED
- Device Name
- Ostomy Products EUDAMED
- Model / Reference
- 201122PC-38 EUDAMED201122 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858892211045 EUDAMED03858892214374 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 L / pre-cut 38mm 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 88ed6a5d-6625-4e78-8f02-2bafca053db4 61 fields · synced Jul 17, 2026
- EUDAMED 535921ad-4fdd-4626-8586-522cc5d5834a 61 fields · synced May 18, 2026