Identity
- Trade Name
- Silicone Thoracic Drain, RF Type EUDAMED
- Device Name
- Silicone Thoracic Drain, RF Type EUDAMED
- Model / Reference
- 2018-0520 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710961936190 EUDAMED
- Basic UDI-DI
- B-04710961936190 EUDAMED
- EMDN Code
- A0601010401 THORACIC DRAINAGES (STRAIGHT AND ANGLED) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium 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 Thoracic Drain, RF Type by Fortune Medical Instrument Corp. — Class IIa — 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-04710961936190 | Class IIa | 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 e0d63709-d250-4ac1-a814-8f7f1cac5767 61 fields · synced May 29, 2026