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Balloon Catheter
EUDAMEDClass IIa (EU MDR)
Ref 331305-000080Ref 331305-000120Ref 331305-000100
Identity
- Trade Name
- Balloon Catheter EUDAMED
- Device Name
- Balloon Catheter EUDAMED
- Model / Reference
- 331305-000080 EUDAMED331305-000120 EUDAMED331305-000100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 44026704717925 EUDAMED44026704717949 EUDAMED44026704717932 EUDAMED
- Basic UDI-DI
- 08019020000000000000254KR EUDAMED
- EMDN Code
- U010206 URETHRAL PROSTATIC AND BLADDER CATHETERS, TIEMANN WITH BALLOON EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Balloon Catheter by Teleflex Medical — Class IIa — 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 | 08019020000000000000254KR | Class IIa | Active |
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Manufacturer
- Manufacturer
- Teleflex Medical
- EUDAMED SRN
- IE-MF-000015868
Sources (3)
- EUDAMED 47a19857-5600-4315-bfe8-ecafca7dbfec 61 fields · synced Jul 23, 2026
- EUDAMED 6bd0fed7-216e-48c6-8c35-965cef5ba4cc 61 fields · synced May 18, 2026
- EUDAMED d2c15a48-d1b7-4235-be6c-f341b93d142f 61 fields · synced Jul 23, 2026