← Back to catalogue
Catheter Spigot
EUDAMEDClass I (EU MDR)
Ref 1820 seriesRef 1820-0000Ref 1820-0002
Identity
- Trade Name
- Catheter Spigot EUDAMED
- Device Name
- Catheter Spigot EUDAMED
- Model / Reference
- 1820 series EUDAMED1820-0000 EUDAMED1820-0002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711182605612 EUDAMED04711182615246 EUDAMED
- Basic UDI-DI
- B-04711182605612 EUDAMED4710961930201010199 EUDAMED
- EMDN Code
- U0280 URETERAL CATHETERS AND STENTS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland EUDAMEDBulgaria 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
Catheter Spigot by Fortune Medical Instrument Corp. — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04711182605612 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-04711182605612 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fortune Medical Instrument Corp.
- EUDAMED SRN
- TW-MF-000009221
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED b087dd0c-068f-457c-b5e6-71d694a1dbf7 61 fields · synced Jul 20, 2026
- EUDAMED b3766382-d5f3-420c-94af-2ecc078a2b60 61 fields · synced Jul 13, 2026
- EUDAMED cef0ea15-5363-4fdb-a4e3-17f2ae25a600 61 fields · synced Jul 15, 2026