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UROMED Transurethral Silicone Balloon Catheter for Children
EUDAMEDClass IIb (EU MDR)
Ref 1340.10
Identity
- Trade Name
- UROMED Transurethral Silicone Balloon Catheter for Children EUDAMED
- Device Name
- TBC01 EUDAMED
- Model / Reference
- 1340.10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250098801331 EUDAMED
- Basic UDI-DI
- 04250098810031ED EUDAMED
- EMDN Code
- U010201 URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
UROMED Transurethral Silicone Balloon Catheter for Children 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 | 04250098810031ED | Class IIb | Active |
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Manufacturer
- Manufacturer
- UROMED Kurt Drews KG
- EUDAMED SRN
- DE-MF-000006084
Sources (1)
- EUDAMED 274c0d43-26ba-4981-9c55-5ff891b88f57 61 fields · synced Jun 18, 2026