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Mono-Flo Drainage Bag 100% Silicone Foley Catheter, Pre-conncected 14 Fr/Ch (4.…
EUDAMEDClass IIb (EU MDR)
Ref 6209141
by Covidien llc
Identity
- Device Name
- Mono-Flo Drainage Bag 100% Silicone Foley Catheter, Pre-conncected 14 Fr/Ch (4.7 mm), 2000 mL EUDAMED
- Model / Reference
- 6209141 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10884521215658 EUDAMED
- Basic UDI-DI
- B-10884521215658 EUDAMED
- EMDN Code
- U0199 URETHRAL PROSTATIC AND BLADDER CATHETERS - 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
Mono-Flo Drainage Bag 100% Silicone Foley Catheter, Pre-conncected 14 Fr/Ch (4.… by Covidien llc — 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-10884521215658 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Covidien llc
- EUDAMED SRN
- US-MF-000017721
- Authorised Representative
- Covidien Ireland Limited IE-AR-000002274
Sources (1)
- EUDAMED 6d9bba23-c1d4-45c8-9e50-d9bfb752acf2 61 fields · synced Jul 30, 2026