Identity
- Trade Name
- LENTELL ColoTouch M EUDAMED
- Device Name
- Ostomy Products EUDAMED
- Model / Reference
- 201102M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858892218600 EUDAMED
- Basic UDI-DI
- 385889221stomaprodsSF EUDAMED
- EMDN Code
- A1001010102 ONE-PIECE COLOSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT, WITH TISSUE COVER 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 ColoTouch M 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 (1)
- EUDAMED 7547b5d5-9c7e-44b2-9710-e62fbe2ba9a2 61 fields · synced Jun 17, 2026