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Rusch Brillant AquaFlate Glycerine Silicone Balloon Catheter with Pre-filled Sy…
EUDAMEDClass IIb (EU MDR)
Ref 178000-000220
Identity
- Trade Name
- Rusch Brillant AquaFlate Glycerine Silicone Balloon Catheter with Pre-filled Syringe EUDAMED
- Device Name
- BRILLANT AQUAFLATE SILICONE 2W 10ML EUDAMED
- Model / Reference
- 178000-000220 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 24026704320671 EUDAMED
- Basic UDI-DI
- B-24026704320671 EUDAMED
- EMDN Code
- U010201 URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland 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
Rusch Brillant AquaFlate Glycerine Silicone Balloon Catheter with Pre-filled Sy… by Teleflex Medical Sdn. Bhd. — Class IIb — MDD — listed in EUDAMED
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-24026704320671 | 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 37310b69-8a83-4125-a29a-71f9d44df808 61 fields · synced Oct 6, 2026