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LENTELL ColoBag II M +1 more model
EUDAMEDClass I (EU MDR)
Ref 201153-1Ref 201153
Identity
- Trade Name
- LENTELL ColoBag II M; transparent EUDAMEDLENTELL ColoBag II M EUDAMED
- Device Name
- Ostomy Products EUDAMED
- Model / Reference
- 201153-1 EUDAMED201153 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858892217849 EUDAMED03858892218082 EUDAMED
- Basic UDI-DI
- 385889221stomaprodsSF EUDAMED
- EMDN Code
- A10020201 COLOSTOMY BAGS FOR TWO-PART SYSTEMS, W/O TISSUE COVER EUDAMEDA10020202 COLOSTOMY BAGS FOR TWO-PART SYSTEMS, WITH TISSUE COVER EUDAMED
- Models / Variants
- LENTELL ColoBag II M 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
LENTELL ColoBag II M +1 more model by Lentismed d.o.o. — Class I — MDR — listed in EUDAMED — 2 models — 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 a23589bd-0c82-46b6-9c2e-982ecd4ad4f8 61 fields · synced Jul 15, 2026
- EUDAMED 32b63c4c-9f5c-4a54-aea9-93282d1ad0f4 61 fields · synced May 18, 2026