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Silicone Round Drain Kit
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 2015-9220Ref CO2015-9214Ref CO2015-9216Ref CO2015-9220Ref CO2015-9218Ref CO2015-9210Ref CO2015-9208Ref 2015-9208
Identity
- Trade Name
- Silicone Round Drain Kit EUDAMEDFDA UDI
- Generic Name
- Closed-wound drain, non-bioabsorbable FDA UDI
- Device Name
- Silicone Round Drain Kit EUDAMED
- Model / Reference
- 2015-9220 EUDAMEDFDA UDI2015-9208 EUDAMEDFDA UDICO2015-9214 EUDAMEDCO2015-9216 EUDAMEDCO2015-9220 EUDAMEDCO2015-9218 EUDAMEDCO2015-9210 EUDAMEDCO2015-9208 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14710961935664 EUDAMEDFDA UDI04711182605308 EUDAMED14710961935619 EUDAMEDFDA UDI14711182629318 EUDAMED04711182605728 EUDAMED04711182605735 EUDAMED14711182605732 EUDAMED14711182605718 EUDAMED04711182611477 EUDAMED14711182611474 EUDAMED14711182605305 EUDAMED04711182605711 EUDAMED
- Basic UDI-DI
- B-14710961935664 EUDAMEDB-04711182605308 EUDAMEDB-14711182629318 EUDAMEDB-04711182605728 EUDAMEDB-04711182605735 EUDAMEDB-14711182605732 EUDAMEDB-14711182605718 EUDAMEDB-04711182611477 EUDAMEDB-14710961935619 EUDAMEDB-14711182611474 EUDAMEDB-14711182605305 EUDAMEDB-04711182605711 EUDAMED
- FDA Product Code
- GCD FDA UDI
- EMDN Code
- A0601010402 CYLINDRICAL OR CIRCULAR DRAINAGES (STRAIGHT AND T-SHAPED) EUDAMED
- GMDN Term
- Closed-wound drain, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4200 FDA UDI
- Market of Registration
- Spain EUDAMEDItaly EUDAMEDPoland EUDAMEDFrance 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
Category: Biliary drain
Silicone Round Drain Kit by Fortune Medical Instrument Corp. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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-14710961935664 | 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 (16)
- EUDAMED d1090190-19f9-4c84-b693-37b9f584a263 61 fields · synced Sep 17, 2026
- EUDAMED d5602227-482a-4719-b731-32f60c750898 61 fields · synced May 19, 2026
- FDA UDI 4e12c301-acb2-4140-b2ad-898b61061260 32 fields · synced May 27, 2026
- FDA UDI 34389483-6652-40ce-a1d9-270cc0da5b87 32 fields · synced May 30, 2026
- EUDAMED cf70902e-3c25-4e41-80fb-766f2e5d1e18 61 fields · synced Jul 9, 2026
- EUDAMED dc8c3ac3-99c0-4e85-b63b-39a51d876ee8 61 fields · synced Jul 9, 2026
- EUDAMED 20bc0030-7816-4b59-96f6-196e3ad91357 61 fields · synced Jul 10, 2026
- EUDAMED bc343e98-5821-48f2-9d02-3b8fd38e56d3 61 fields · synced Jul 12, 2026
- EUDAMED 45af2ccb-1925-4c4d-a7b1-7ba361f0f3c4 61 fields · synced Jul 13, 2026
- EUDAMED 0f2209d3-aadf-4fc2-939b-cff880ace868 61 fields · synced Jul 18, 2026
- EUDAMED e07571b2-f1a5-4577-a73b-acf0c0e8a4ae 61 fields · synced Jul 19, 2026
- EUDAMED 4ffa4379-c858-4aff-8a94-3d30d5a53d44 61 fields · synced Jul 21, 2026
- EUDAMED 2c84c0fc-eeae-49cb-b22e-2622ba53637d 61 fields · synced Jul 22, 2026
- EUDAMED 3832cbae-db63-4978-8963-2547e32be20c 61 fields · synced Jul 24, 2026
- EUDAMED 84f1db3c-b24f-4c6f-b153-02ef3a5a85fe 61 fields · synced Jul 31, 2026
- EUDAMED 77e942b1-ce9c-4731-a6d2-f36b60a47148 61 fields · synced Sep 17, 2026