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RUSCH Sensor (Series 400) Silicone Balloon Catheter for the Measuring of Temper…
EUDAMEDClass IIb (EU MDR)
Ref 179360-000160
Identity
- Trade Name
- RUSCH Sensor (Series 400) Silicone Balloon Catheter for the Measuring of Temperature EUDAMED
- Device Name
- FOLEY WITH TEMP. SENSOR EUDAMED
- Model / Reference
- 179360-000160 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 24026704103847 EUDAMED
- Basic UDI-DI
- B-24026704103847 EUDAMED
- EMDN Code
- U0103 URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
RUSCH Sensor (Series 400) Silicone Balloon Catheter for the Measuring of Temper… 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-24026704103847 | 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 098f09c9-3f60-4927-8b7d-2090c00c0f4e 61 fields · synced Jul 8, 2026