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Foledrain
EUDAMEDClass IIa (EU MDR)
Ref 8906065483937Model Foley Balloon Catheter - Latex/Silicon (2 Way/3 Way)
Identity
- Trade Name
- Foledrain EUDAMED
- Device Name
- Foley Balloon Catheter EUDAMED
- Model / Reference
- Foley Balloon Catheter - Latex/Silicon (2 Way/3 Way) EUDAMED8906065483937 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906065483937 EUDAMED
- Basic UDI-DI
- 890606548U03NS EUDAMED
- Direct Marketing DI
- 08906065483937 EUDAMED
- EMDN Code
- U0199,U020199 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Foledrain by Mais India Medical Devices Pvt. Ltd. — Class IIa — 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 | 890606548U03NS | Class IIa | Active |
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Manufacturer
- Manufacturer
- Mais India Medical Devices Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000021842
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 622e8eba-2112-473f-8a4d-2a4523b2b867 61 fields · synced Oct 6, 2026