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Silicone Round Drain Tube
EUDAMEDClass IIa (EU MDR)
Ref CO2015-0210Ref CO2015-0214Ref A0601010402Model CO2015-0220Ref CO2015-0216Ref 2015-0208Ref CO2015-0208
Identity
- Trade Name
- Silicone Round Drain Tube EUDAMEDSilicone Round Drain EUDAMED
- Device Name
- Silicone Round Drain Tube EUDAMEDSilicone Round Drain EUDAMED
- Model / Reference
- CO2015-0210 EUDAMEDCO2015-0214 EUDAMEDCO2015-0220 EUDAMEDA0601010402 EUDAMEDCO2015-0216 EUDAMED2015-0208 EUDAMEDCO2015-0208 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14711182605268 EUDAMED04711182605278 EUDAMED14711182605299 EUDAMED04711182605261 EUDAMED14711182605282 EUDAMED04711182605292 EUDAMED04710961935551 EUDAMED04711182605285 EUDAMED14711182605275 EUDAMED04711182629366 EUDAMED
- Basic UDI-DI
- B-14711182605268 EUDAMEDB-04711182605278 EUDAMEDB-14711182605299 EUDAMEDB-04711182605261 EUDAMEDB-14711182605282 EUDAMEDB-04711182605292 EUDAMEDB-04710961935551 EUDAMEDB-04711182605285 EUDAMEDB-14711182605275 EUDAMEDB-04711182629366 EUDAMED
- EMDN Code
- A0601010402 CYLINDRICAL OR CIRCULAR DRAINAGES (STRAIGHT AND T-SHAPED) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMEDPoland EUDAMEDDenmark EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Silicone Round Drain Tube by Fortune Medical Instrument Corp. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-14711182605268 | Class IIa | Active |
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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 (10)
- EUDAMED acc3e862-71e7-4711-85b9-e5d124071842 61 fields · synced Sep 18, 2026
- EUDAMED db131453-47e6-47e0-95f4-a03ab948290a 61 fields · synced May 16, 2026
- EUDAMED b5c7a06b-f255-401d-b476-729e964f19bc 61 fields · synced May 16, 2026
- EUDAMED 1e328180-86eb-4789-a74e-7dbe8f30b377 61 fields · synced May 17, 2026
- EUDAMED 83a7ea08-400c-49cc-8078-d0357b400b58 61 fields · synced May 17, 2026
- EUDAMED d8f4da23-2ba4-4788-840e-be78062a85d1 61 fields · synced May 17, 2026
- EUDAMED 1ef60831-52b5-4311-8b44-81b4c1c2a35e 61 fields · synced May 17, 2026
- EUDAMED c87c4fdc-b271-4272-b1e6-8ad0e0f9e8ee 61 fields · synced May 17, 2026
- EUDAMED eee30e19-4859-49e1-b601-bea5c38dd073 61 fields · synced May 19, 2026
- EUDAMED 4b96b2f4-899b-4858-9dd1-2afbf92fc9cd 61 fields · synced May 19, 2026