Identity
- Trade Name
- LENTELL FistulaTouch L; transparent EUDAMED
- Device Name
- Ostomy Products EUDAMED
- Model / Reference
- 201150 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858892218204 EUDAMED
- Basic UDI-DI
- 385889221stomaprodsSF EUDAMED
- EMDN Code
- A100199 DEVICES FOR ABDOMINAL OSTOMY - ONE PIECE - OTHER EUDAMED
- Models / Variants
- LENTELL FistulaTouch L EUDAMEDtransparent 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
Category: One-piece intestinal ostomy bag, closed-ended
LENTELL FistulaTouch L +1 more model by Lentismed d.o.o. — Class I — MDR — listed in EUDAMED — 2 models — regulatory data on deviCERTS
Similar devices
Also classified as One-piece intestinal ostomy bag, closed-ended.
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- SenSura Mio Concave — Coloplast A/S · Class I
- Hollister — Hollister Incorporated · Class I
- SenSura Mio — Coloplast A/S · Class I
- SenSura Mio Convex — Coloplast A/S · Class I
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 (1)
- EUDAMED 39e8fb15-1aa9-4d96-9676-5d644b832958 61 fields · synced Jun 19, 2026