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Silicone Sump Drain Tube
EUDAMEDClass IIa (EU MDR)
Ref 2016-0220Ref 2016-0214Ref 2016-0314Ref 2016-0114
Identity
- Trade Name
- Silicone Sump Drain Tube EUDAMED
- Device Name
- Silicone Sump Drain Tube EUDAMED
- Model / Reference
- 2016-0220 EUDAMED2016-0214 EUDAMED2016-0314 EUDAMED2016-0114 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710961935889 EUDAMED04710961935872 EUDAMED04710961935896 EUDAMED04710961935858 EUDAMED
- Basic UDI-DI
- B-04710961935889 EUDAMEDB-04710961935872 EUDAMEDB-04710961935896 EUDAMEDB-04710961935858 EUDAMED
- EMDN Code
- A060206 PERITONAEAL DRAINAGES AND KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMEDGermany 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 Sump 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-04710961935889 | 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 9349ae7d-4619-45b6-8337-f4ada26d82b8 61 fields · synced Jul 29, 2026
- EUDAMED 042d55dc-4e5e-45c4-b54f-8d7a6c4dc465 61 fields · synced May 17, 2026
- EUDAMED c7cc1bff-6d06-44d2-a455-58addea1f042 61 fields · synced May 18, 2026
- EUDAMED c9c4d1d8-60d0-44f5-acdd-a8b9435e323d 61 fields · synced May 19, 2026