Identity
- Trade Name
- Silicone Nephrostomy Catheter EUDAMED
- Device Name
- Silicone Nephrostomy Catheter EUDAMED
- Model / Reference
- 1854-0210 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710961933144 EUDAMED
- Basic UDI-DI
- B-04710961933144 EUDAMED
- EMDN Code
- U040203 NEPHROSTOMY CATHETERS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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 Nephrostomy Catheter 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-04710961933144 | 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 (1)
- EUDAMED 7e2cc8e9-14c9-4eec-8fe6-a5d381a57193 61 fields · synced Jun 18, 2026