Identity
- Trade Name
- UROMED Temperature Measurement Catheter EUDAMED
- Device Name
- TMC01 EUDAMED
- Model / Reference
- 1600.18 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250098849739 EUDAMED
- Basic UDI-DI
- 04250098810085F4 EUDAMED
- EMDN Code
- U0103 URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
UROMED Temperature Measurement Catheter by UROMED Kurt Drews KG — Class IIb — 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 | 04250098810085F4 | Class IIb | Active |
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Manufacturer
- Manufacturer
- UROMED Kurt Drews KG
- EUDAMED SRN
- DE-MF-000006084
Sources (1)
- EUDAMED dadc988d-d1e3-4e22-b70b-5389641b905a 61 fields · synced Oct 5, 2026