Identity
- Trade Name
- LENTELL O'Wipe EUDAMED
- Device Name
- Ostomy Accessories EUDAMED
- Model / Reference
- 201131W EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858892219829 EUDAMED
- Basic UDI-DI
- 385889221stomaaccssHJ EUDAMED
- EMDN Code
- A108005 DEVICES FOR THE REMOVAL OF ADHESIVES FROM THE PERISTOMAL SKIN 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 O'Wipe 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 (2)
- EUDAMED a6e9f04a-4d8a-4dea-8171-56996ace7775 61 fields · synced Sep 18, 2026
- EUDAMED 6d20662f-6f42-4b1a-9245-1ba5aeceeb2c 61 fields · synced Aug 1, 2026