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Silicone Hub-less Endo Drain Tube
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 2015-0719Ref 2015-0729Ref 2015-0715Ref 2015-0710
Identity
- Trade Name
- Silicone Hub-less Endo Drain Tube EUDAMEDSilicone Hubless Endo-Drain Tube FDA UDI
- Generic Name
- Closed-wound drain, non-bioabsorbable FDA UDI
- Device Name
- Silicone Hub-less Endo Drain Tube EUDAMED
- Model / Reference
- 2015-0719 EUDAMEDFDA UDI2015-0729 EUDAMED2015-0715 EUDAMED2015-0710 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14711182606050 EUDAMEDFDA UDI04711182606091 EUDAMED04711182606046 EUDAMED04711182606053 EUDAMED04711182606039 EUDAMED
- Basic UDI-DI
- B-14711182606050 EUDAMEDB-04711182606091 EUDAMEDB-04711182606046 EUDAMEDB-04711182606053 EUDAMEDB-04711182606039 EUDAMED
- FDA Product Code
- GCD FDA UDI
- EMDN Code
- A0601010402 CYLINDRICAL OR CIRCULAR DRAINAGES (STRAIGHT AND T-SHAPED) EUDAMEDA0601010403 FLAT AND LAMELLAR DRAINAGES 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
- Malta EUDAMEDDenmark EUDAMEDGermany 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 Hub-less Endo Drain 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-14711182606050 | 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 (6)
- EUDAMED bbfe0cb2-3d10-4d1b-9e9d-3112f16fb095 61 fields · synced Jul 18, 2026
- FDA UDI ae98dd54-a8c0-4253-8122-b7f327445165 32 fields · synced May 30, 2026
- EUDAMED ce88f80d-2183-433c-afb3-df343d642eae 61 fields · synced Jul 9, 2026
- EUDAMED 26dd5031-10cc-4fd7-82e7-2e4a2c71338e 61 fields · synced Jul 12, 2026
- EUDAMED f8a825b5-0d55-4aeb-917c-7788463b457c 61 fields · synced Jul 12, 2026
- EUDAMED 58c53393-fc6e-43c6-8ae5-e2f63b56fcbc 61 fields · synced Jul 18, 2026