Identity
- Trade Name
- CompactCath Tiemann, Male, 8 Fr/Ch, 40cm EUDAMED
- Device Name
- Pre-lubricated urinary catheter EUDAMED
- Model / Reference
- 101619 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858892212103 EUDAMED
- Basic UDI-DI
- 385889221cathetersgelPA EUDAMED
- EMDN Code
- U01010601 TIEMANN CATHETERS, SELF-LUBRICATING EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Croatia EUDAMED
Clinical & Handling
Sterile
Yes
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
CompactCath Tiemann, Male, 8 Fr/Ch, 40cm 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 | 385889221cathetersgelPA | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lentismed d.o.o.
- EUDAMED SRN
- HR-MF-000018298
Sources (1)
- EUDAMED 2a24d3b6-81ca-48be-8151-70b51e46e7a6 61 fields · synced Jul 11, 2026