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Superglide (Silicone) Nephrostomy Balloon Catheter, w. Stylet
EUDAMEDClass IIb (EU MDR)
Ref 340408-000160Ref 340409-000240Ref 340409-000200Ref 340408-000120Ref 340409-000180Ref 340409-000140Ref 340409-000120Ref 340408-000240Ref 340409-000160
Identity
- Trade Name
- Superglide (Silicone) Nephrostomy Balloon Catheter, w. Stylet EUDAMED
- Device Name
- SUPERGLIDE CATHETER SILICONE 2W 5ML EUDAMEDSUPERGLIDE CATHETER SILICONE 2W 3ML EUDAMED
- Model / Reference
- 340408-000160 EUDAMED340409-000240 EUDAMED340409-000200 EUDAMED340408-000120 EUDAMED340409-000180 EUDAMED340409-000140 EUDAMED340409-000120 EUDAMED340408-000240 EUDAMED340409-000160 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 24026704104592 EUDAMED24026704104707 EUDAMED24026704104684 EUDAMED24026704104578 EUDAMED24026704104677 EUDAMED24026704104653 EUDAMED24026704104646 EUDAMED24026704104639 EUDAMED24026704104660 EUDAMED
- Basic UDI-DI
- B-24026704104592 EUDAMEDB-24026704104707 EUDAMEDB-24026704104684 EUDAMEDB-24026704104578 EUDAMEDB-24026704104677 EUDAMEDB-24026704104653 EUDAMEDB-24026704104646 EUDAMEDB-24026704104639 EUDAMEDB-24026704104660 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-24026704104592 | 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 (9)
- EUDAMED 8f8f7091-b6ca-4158-a8ce-f95c9b5c0996 61 fields · synced Aug 2, 2026
- EUDAMED c1833bf8-d544-4f4a-9ac5-d5254a7675ba 61 fields · synced May 16, 2026
- EUDAMED cbfc131e-167f-48be-9e76-e1136e9c2a5d 61 fields · synced May 16, 2026
- EUDAMED f571458a-5339-4622-ab25-e441a6bee577 61 fields · synced May 17, 2026
- EUDAMED 21085720-e954-4e95-b101-31029aec08ab 61 fields · synced May 17, 2026
- EUDAMED 0543c7d2-4f67-4569-a276-d0ffda443b22 61 fields · synced May 17, 2026
- EUDAMED 84b82416-b60d-472f-bceb-5de8c3c3b162 61 fields · synced May 17, 2026
- EUDAMED 49a148d8-2475-4596-b2c4-b1880f5fcfae 61 fields · synced May 17, 2026
- EUDAMED 383c4a25-dea3-4886-9e7c-0d64b089ea39 61 fields · synced May 18, 2026