Identity
- Trade Name
- CATHETER SPIGOT EUDAMED
- Device Name
- Catheter Spigot EUDAMED
- Model / Reference
- 1820-0000 EUDAMEDCP18200000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711182610586 EUDAMED
- Basic UDI-DI
- 4710961930201010199 EUDAMED
- EMDN Code
- U0280 URETERAL CATHETERS AND STENTS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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 — 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 | 4710961930201010199 | Class I | 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 (1)
- EUDAMED 5cdd29e4-7ec8-4084-abd9-d836d05eca2d 61 fields · synced Jun 18, 2026