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Aquaflate Brillant Female 2 Way (All Silicone)
EUDAMEDClass IIb (EU MDR)
Ref A210120
Identity
- Trade Name
- Aquaflate Brillant Female 2 Way (All Silicone) EUDAMED
- Device Name
- Silicone Suprapubic Catheter EUDAMED
- Model / Reference
- A210120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14026704730596 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 Female 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 beecd833-d5db-4a2e-a956-ffa9a21a4cda 61 fields · synced Jun 19, 2026