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Silicone T Drainage Tube
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1910-0022Ref 1910-0010Ref 1910-0018Ref 1910-0008Ref 1910-0012Ref 1910-0024Ref 1910-0014Ref 1910-0005Ref 1910-0016Ref 1910-0020
Identity
- Trade Name
- Silicone T Drainage Tube EUDAMEDFDA UDI
- Generic Name
- Biliary drain FDA UDI
- Device Name
- Silicone T Drainage Tube EUDAMED
- Model / Reference
- 1910-0022 EUDAMED1910-0010 EUDAMED1910-0018 EUDAMEDFDA UDI1910-0008 EUDAMED1910-0012 EUDAMED1910-0024 EUDAMED1910-0014 EUDAMED1910-0005 EUDAMED1910-0016 EUDAMED1910-0020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 34710961934333 EUDAMED14710961934278 EUDAMED14710961934315 EUDAMED34710961934265 EUDAMED34710961934289 EUDAMED34710961934340 EUDAMED34710961934296 EUDAMED14711182607439 EUDAMED04710961934318 EUDAMEDFDA UDI34710961934302 EUDAMED14710961934322 EUDAMED14710961934292 EUDAMED
- Basic UDI-DI
- B-34710961934333 EUDAMEDB-14710961934278 EUDAMEDB-14710961934315 EUDAMEDB-34710961934265 EUDAMEDB-34710961934289 EUDAMEDB-34710961934340 EUDAMEDB-34710961934296 EUDAMEDB-14711182607439 EUDAMEDB-04710961934318 EUDAMEDB-34710961934302 EUDAMEDB-14710961934322 EUDAMEDB-14710961934292 EUDAMED
- 510(k) Number
- K980917 FDA UDI
- FDA Product Code
- GCA FDA UDI
- EMDN Code
- A0601010402 CYLINDRICAL OR CIRCULAR DRAINAGES (STRAIGHT AND T-SHAPED) EUDAMED
- GMDN Term
- Biliary drain FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5010 FDA UDI
- Market of Registration
- Malta EUDAMEDCzechia EUDAMEDRomania EUDAMEDBelgium 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
No
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 T Drainage Tube 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-34710961934333 | 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 (13)
- EUDAMED 7f1ad010-f206-46ca-9015-5ea51aee61b0 61 fields · synced Aug 3, 2026
- EUDAMED 760e83e8-4229-4cdd-b836-0064d860324e 61 fields · synced May 17, 2026
- EUDAMED 0d06c9ba-3820-4631-accd-6b14454def46 61 fields · synced May 17, 2026
- EUDAMED b41b3cbb-aa78-471f-8266-d1eb4bd2b03f 61 fields · synced May 17, 2026
- EUDAMED c6a1c226-7530-4870-ac98-dbbcd59115d0 61 fields · synced May 17, 2026
- EUDAMED c6bbeb6b-9611-4a30-b39b-2ed7f267f937 61 fields · synced May 18, 2026
- EUDAMED 5a6ff2a4-10a7-40de-9440-b478ce5de990 61 fields · synced May 18, 2026
- EUDAMED 829f309f-90f0-45ca-8d53-b0eac7601941 61 fields · synced May 19, 2026
- EUDAMED 491644ed-beea-469e-9af8-e55943d4444c 61 fields · synced May 19, 2026
- EUDAMED dd1fe769-367b-47d6-b6e3-dfa2792d2296 61 fields · synced May 19, 2026
- EUDAMED 9f1a8f5d-bc9a-44c7-9c4f-db55fee60ac3 61 fields · synced May 19, 2026
- FDA UDI 962e037f-b30e-42ba-89f3-432721c745e1 33 fields · synced May 29, 2026
- EUDAMED 29f2054b-f6f6-4b10-845b-1b6a03856f2a 61 fields · synced Jul 9, 2026