Identity
- Trade Name
- Aquaflate Brillant 2 Way (All Silicone) EUDAMED
- Device Name
- Silicone Suprapubic Catheter EUDAMED
- Model / Reference
- DA310114 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14026704730756 EUDAMED
- Basic UDI-DI
- 08019020000000000000195L2 EUDAMED
- EMDN Code
- U040199 DEVICES FOR SUPRAPUBIC URINARY DRAINAGE - OTHER 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
Aquaflate Brillant 2 Way (All Silicone) by Teleflex Medical Sdn. Bhd. — Class IIb — 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 | 08019020000000000000195L2 | 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 a3dbdd67-a909-4b3f-9d28-534b5a4ed897 61 fields · synced Jul 17, 2026