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silicone 2-way Foley Cathrter
EUDAMEDClass IIb (EU MDR)
Ref 4833-0512Ref 4833-0522Ref 4833-0516
Identity
- Trade Name
- silicone 2-way Foley Cathrter EUDAMED
- Device Name
- silicone 2-way Foley Cathrter EUDAMED
- Model / Reference
- 4833-0512 EUDAMED4833-0522 EUDAMED4833-0516 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711182608071 EUDAMED04711182608125 EUDAMED04711182608095 EUDAMED
- Basic UDI-DI
- B-04711182608071 EUDAMEDB-04711182608125 EUDAMEDB-04711182608095 EUDAMED
- EMDN Code
- U020299 URETERAL CATHETERS WITH BALLOON - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
silicone 2-way Foley Cathrter by Fortune Medical Instrument Corp. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-04711182608071 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Fortune Medical Instrument Corp.
- EUDAMED SRN
- TW-MF-000009221
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 4f4b1cdf-2756-414b-b985-dd246e983ed8 61 fields · synced Sep 17, 2026
- EUDAMED d4546704-edf4-4db8-855f-c06d11291a62 61 fields · synced May 18, 2026
- EUDAMED cc3d3d01-745f-4914-8821-63c8062916e6 61 fields · synced May 18, 2026