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Silicone Thoracic Drain, SF Type
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 2018-0124
Identity
- Trade Name
- Silicone Thoracic Drain, SF Type EUDAMEDFDA UDI
- Generic Name
- Pleural catheter FDA UDI
- Device Name
- Silicone Thoracic Drain, SF Type EUDAMED
- Model / Reference
- 2018-0124 EUDAMED2018-0120 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04710961936138 EUDAMED14710961936128 FDA UDI
- Basic UDI-DI
- B-04710961936138 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, SF 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-04710961936138 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (2)
- EUDAMED 32762746-a9b1-4fc3-990c-755d2672a2ec 61 fields · synced Jul 18, 2026
- FDA UDI 01a538a1-a888-4dba-8949-e3bd6612b512 32 fields · synced May 26, 2026