Identity
- Trade Name
- Lentell OstoStrip EUDAMED
- Device Name
- Ostomy Accessories EUDAMED
- Model / Reference
- 201144 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858892212226 EUDAMED
- Basic UDI-DI
- 385889221stomaaccssHJ EUDAMED
- EMDN Code
- A108008 ADHESIVES FOR ABDOMINAL OSTOMY DEVICES 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 OstoStrip 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 | 385889221stomaaccssHJ | Class I | Active |
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Manufacturer
- Manufacturer
- Lentismed d.o.o.
- EUDAMED SRN
- HR-MF-000018298
Sources (1)
- EUDAMED cd4eff29-9632-4abc-9397-7c09fe73aa09 61 fields · synced Jun 20, 2026