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Silicone Nephrostomie Balloon Catheter
EUDAMEDClass IIb (EU MDR)
Ref 340502-000160
Identity
- Trade Name
- Silicone Nephrostomie Balloon Catheter EUDAMED
- Device Name
- CATHETER NEPHROSTOMY SILICONE 2W 5M EUDAMED
- Model / Reference
- 340502-000160 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 24026704049589 EUDAMED
- Basic UDI-DI
- B-24026704049589 EUDAMED
- EMDN Code
- U040203 NEPHROSTOMY CATHETERS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
Silicone Nephrostomie Balloon Catheter by Teleflex Medical Sdn. Bhd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-24026704049589 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Teleflex Medical Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000024692
- Authorised Representative
- Teleflex Medical IE-AR-000015869
Sources (1)
- EUDAMED 5b10db47-fcb1-4438-a70a-cd757813427b 61 fields · synced Jun 17, 2026