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Silicone Flat Drain
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref PR2014-0102Ref PR2014-0072Ref PR2014-0071Ref CO2014-0101Ref 2014-0052Ref CO2014-0132Ref CO2014-0071Ref CO2014-0102Ref PR2014-0132Ref 2014-0072Ref 2014-0102Ref CO2014-0072
Identity
- Trade Name
- Silicone Flat Drain EUDAMEDFDA UDI
- Generic Name
- Closed-wound drain, non-bioabsorbable FDA UDI
- Device Name
- Silicone Flat Drain EUDAMED
- Model / Reference
- PR2014-0102 EUDAMEDPR2014-0072 EUDAMEDPR2014-0071 EUDAMEDCO2014-0101 EUDAMED2014-0052 EUDAMEDFDA UDICO2014-0132 EUDAMEDCO2014-0071 EUDAMEDCO2014-0102 EUDAMEDPR2014-0132 EUDAMED2014-0072 EUDAMEDFDA UDI2014-0102 EUDAMEDFDA UDICO2014-0072 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711182605001 EUDAMED04711182604981 EUDAMED04711182604974 EUDAMED14711182605008 EUDAMED04711182619879 EUDAMED04710961934967 EUDAMED04711182605681 EUDAMED04711182605698 EUDAMED04711182605674 EUDAMED14711182605015 EUDAMED04710961934981 EUDAMED14710961935008 EUDAMEDFDA UDI14710961934988 EUDAMEDFDA UDI14710961934964 EUDAMEDFDA UDI14711182605695 EUDAMED14711182604971 EUDAMED14711182605671 EUDAMED14711182605664 EUDAMED14711182605688 EUDAMED
- Basic UDI-DI
- B-04711182605001 EUDAMEDB-04711182604981 EUDAMEDB-04711182604974 EUDAMEDB-14711182605008 EUDAMEDB-04711182619879 EUDAMEDB-04710961934967 EUDAMEDB-04711182605681 EUDAMEDB-04711182605698 EUDAMEDB-04711182605674 EUDAMEDB-14711182605015 EUDAMEDB-04710961934981 EUDAMEDB-14710961935008 EUDAMEDB-14710961934964 EUDAMEDB-14711182605695 EUDAMEDB-14711182604971 EUDAMEDB-14711182605671 EUDAMEDB-14711182605664 EUDAMEDB-14710961934988 EUDAMEDB-14711182605688 EUDAMED
- FDA Product Code
- GCD FDA UDI
- EMDN Code
- A0601010403 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
- Spain EUDAMEDItaly EUDAMEDGermany EUDAMEDHungary 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: Closed-wound drain, non-bioabsorbable
Silicone Flat Drain by Fortune Medical Instrument Corp. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Closed-wound drain, non-bioabsorbable.
- Argyle — Cardinal Health 200, LLC · Class II
- ReSolve® — Merit Medical Systems, Inc. · Class I
- One-Step™ — Merit Medical Systems, Inc. · Class I
- Argyle — Cardinal Health 200, LLC · Class II
- SKATER™ Mini-Loop Drainage Set — Argon Medical Devices, Inc. · Class I
- Drainage Tube and Accessories — Hangzhou Fushan Medical Appliances Co., Ltd. · Class IIa
- Exodus — NAVILYST MEDICAL, INC. · Class II
- One-Step™ — Merit Medical Systems, Inc. · Class I
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-04711182605001 | 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 (22)
- EUDAMED 4ffff8fc-3e6e-4296-bbab-78a291de6ad1 61 fields · synced Aug 2, 2026
- EUDAMED 6d561422-b85f-4b35-abc7-9056d2ae23f3 61 fields · synced May 17, 2026
- EUDAMED c02cad6b-032c-4ecc-ac7d-2769ffcce19b 61 fields · synced May 17, 2026
- EUDAMED 9300afe5-739a-4e01-b23c-2b8c67f40552 61 fields · synced May 17, 2026
- EUDAMED e34f6de9-de56-4756-84ae-0368ca2f9ada 61 fields · synced May 17, 2026
- EUDAMED 993e35e8-21b2-4da6-8ee5-54f2216c7f05 61 fields · synced May 18, 2026
- EUDAMED 79edafd8-89c9-4837-8ce4-9abe9d874eab 61 fields · synced May 18, 2026
- EUDAMED b593106c-11da-4b6c-86c1-0720329f044a 61 fields · synced May 18, 2026
- EUDAMED 948daa3f-5452-4fef-9039-a1023e5f15a3 61 fields · synced May 18, 2026
- EUDAMED d4e65376-0fb7-44cc-aca6-075d73eeb6be 61 fields · synced May 19, 2026
- EUDAMED 607d30d8-4b18-4555-814f-d48cce69a601 61 fields · synced May 19, 2026
- FDA UDI 02331fbb-db07-4f3e-9751-914d1ea6a98f 32 fields · synced May 30, 2026
- FDA UDI 4aba465c-d42f-41f0-8762-6f4c0fe8da24 32 fields · synced May 30, 2026
- FDA UDI 1d69b43a-1147-4a2c-9e25-06931cab3d99 32 fields · synced May 30, 2026
- EUDAMED 96858d0d-7dcd-4356-a739-ccdc31360c7c 61 fields · synced Jul 8, 2026
- EUDAMED 7ed507f9-e381-440b-b7ee-d3e7de4e2759 61 fields · synced Jul 10, 2026
- EUDAMED 906f0b7c-7a22-44a6-93b1-8a3eaa5a8dff 61 fields · synced Jul 14, 2026
- EUDAMED bea4c16f-2320-4971-9b46-02dd606c7016 61 fields · synced Jul 16, 2026
- EUDAMED 104d82b9-7342-4b83-a294-49d11158111b 61 fields · synced Jul 19, 2026
- EUDAMED 4bc54a35-692a-49f4-9b76-27dff8c5e005 61 fields · synced Jul 20, 2026
- EUDAMED bf72070c-b579-4527-b781-ab4213d80429 61 fields · synced Jul 22, 2026
- EUDAMED 7a64fcab-c77c-4439-b963-8609f707b59e 61 fields · synced Jul 22, 2026