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Silicone Vac Drain, Round
EUDAMEDClass IIa (EU MDR)
Ref PR2114-0403Ref CO2014-0415Ref PR2114-0405Ref CO2014-0419
Identity
- Trade Name
- Silicone Vac Drain, Round EUDAMED
- Device Name
- Silicone Vac Drain, Round EUDAMED
- Model / Reference
- PR2114-0403 EUDAMEDCO2014-0415 EUDAMEDPR2114-0405 EUDAMEDCO2014-0419 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711182605124 EUDAMED04711182605315 EUDAMED04711182605131 EUDAMED14711182605312 EUDAMED14711182606166 EUDAMED
- Basic UDI-DI
- B-04711182605124 EUDAMEDB-04711182605315 EUDAMEDB-04711182605131 EUDAMEDB-14711182605312 EUDAMEDB-14711182606166 EUDAMED
- EMDN Code
- A0601010403 FLAT AND LAMELLAR DRAINAGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMEDItaly 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
Category: Closed-wound drain, non-bioabsorbable
Silicone Vac Drain, Round by Fortune Medical Instrument Corp. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-04711182605124 | 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 (5)
- EUDAMED 1048763e-5033-41ee-8a3f-47af868a7ed9 61 fields · synced Sep 17, 2026
- EUDAMED 147de096-ae4d-484e-be84-0c5b4e942ed4 61 fields · synced May 17, 2026
- EUDAMED 40f87ff7-da39-428a-97e8-6dcb97ae9fbc 61 fields · synced May 18, 2026
- EUDAMED 05fdab0f-7620-4533-9f06-2060c29e55f3 61 fields · synced Jun 20, 2026
- EUDAMED f67a5a8d-f87b-4d59-940c-d367539295c2 61 fields · synced Jul 9, 2026