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Superglide (Silicone) Nephrostomy Balloon Catheter, w. Stylet
EUDAMEDClass IIb (EU MDR)
Ref 340408-000220
Identity
- Trade Name
- Superglide (Silicone) Nephrostomy Balloon Catheter, w. Stylet EUDAMED
- Device Name
- SUPERGLIDE CATHETER SILICONE 2W 5ML EUDAMED
- Model / Reference
- 340408-000220 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 24026704104622 EUDAMED
- Basic UDI-DI
- B-24026704104622 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
Superglide (Silicone) Nephrostomy Balloon Catheter, w. Stylet 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-24026704104622 | 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 92413f46-9e80-4251-b459-f05e5ff1599c 61 fields · synced Jun 18, 2026