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LENTELL coloTouch S - transparent
EUDAMEDClass I (EU MDR)
Ref 201101-1Ref 201101
Identity
- Trade Name
- LENTELL coloTouch S - transparent EUDAMEDLENTELL ColoTouch S EUDAMED
- Device Name
- Ostomy Products EUDAMED
- Model / Reference
- 201101-1 EUDAMED201101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858892214541 EUDAMED03858892214008 EUDAMED
- Basic UDI-DI
- 385889221stomaprodsSF EUDAMED
- EMDN Code
- A1001010101 ONE-PIECE COLOSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT, W/O TISSUE COVER EUDAMEDA1001010102 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 S - transparent 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 5370b845-6f56-4841-baa9-f4c4f9670b37 61 fields · synced Jul 16, 2026
- EUDAMED 5e594429-b706-4a15-bc64-3533bf3789ad 61 fields · synced May 18, 2026