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Silicone Vac Drain, Flat
EUDAMEDClass IIa (EU MDR)
Ref CO2014-0411Ref CO2014-0421Ref CO2014-0408
Identity
- Trade Name
- Silicone Vac Drain,Flat EUDAMEDSILICONE VAC-DRAIN EUDAMED
- Device Name
- Silicone Vac Drain,Flat EUDAMEDSILICONE VAC-DRAIN EUDAMED
- Model / Reference
- CO2014-0411 EUDAMEDCO2014-0421 EUDAMEDCO2014-0408 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711182606176 EUDAMED14711182606173 EUDAMED14711182611467 EUDAMED14711182604209 EUDAMED
- Basic UDI-DI
- B-04711182606176 EUDAMEDB-14711182606173 EUDAMEDB-14711182611467 EUDAMEDB-14711182604209 EUDAMED
- EMDN Code
- A0601010403 FLAT AND LAMELLAR DRAINAGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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, Flat 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-04711182606176 | 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 (4)
- EUDAMED 0657ea6c-b9f3-4016-80a6-6e57f3ce7d91 61 fields · synced Jul 11, 2026
- EUDAMED b26297b4-99e7-40c7-9dd3-f6defd827ca9 61 fields · synced Jul 9, 2026
- EUDAMED 9727444f-2ada-4469-bbf9-4110dbcd8b5c 61 fields · synced Jul 10, 2026
- EUDAMED ba38877a-d704-4ee6-935d-3ef13d2f9955 61 fields · synced Jul 11, 2026