← Back to catalogue
Silicone Thoracic Drain, RF Type
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 2018-0528
Identity
- Trade Name
- Silicone Thoracic Drain, RF Type EUDAMEDFDA UDI
- Generic Name
- Pleural catheter FDA UDI
- Device Name
- Silicone Thoracic Drain, RF Type EUDAMED
- Model / Reference
- 2018-0528 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 14710961936210 EUDAMEDFDA UDI
- Basic UDI-DI
- B-14710961936210 EUDAMED
- FDA Product Code
- GBS FDA UDI
- EMDN Code
- A0601010401 THORACIC DRAINAGES (STRAIGHT AND ANGLED) EUDAMED
- GMDN Term
- Pleural catheter FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4200 FDA UDI
- Market of Registration
- Slovakia EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Silicone Thoracic Drain, RF Type by Fortune Medical Instrument Corp. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-14710961936210 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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 (2)
- EUDAMED c73118ae-7dce-4ba8-87e9-34afa6fcb2f2 61 fields · synced Jun 8, 2026
- FDA UDI 610ee960-c27b-437b-96d0-2cf06525a55e 32 fields · synced May 30, 2026