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Silicone Endo Drain
EUDAMEDClass IIa (EU MDR)
Ref 2015-0621Ref 2015-0610Ref 2015-0615Ref 2015-0624Ref 2015-0619
Identity
- Trade Name
- Silicone Endo Drain EUDAMED
- Device Name
- Silicone Endo Drain EUDAMED
- Model / Reference
- 2015-0621 EUDAMED2015-0610 EUDAMED2015-0615 EUDAMED2015-0624 EUDAMED2015-0619 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710961935803 EUDAMED04710961935773 EUDAMED04710961935780 EUDAMED04711182605520 EUDAMED04710961935797 EUDAMED
- Basic UDI-DI
- B-04710961935803 EUDAMEDB-04710961935773 EUDAMEDB-04710961935780 EUDAMEDB-04711182605520 EUDAMEDB-04710961935797 EUDAMED
- EMDN Code
- A0601010402 CYLINDRICAL OR CIRCULAR DRAINAGES (STRAIGHT AND T-SHAPED) EUDAMEDA0601010403 FLAT AND LAMELLAR DRAINAGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Lithuania EUDAMEDSpain EUDAMEDDenmark EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
EUDAMEDEUDAMED
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: Biliary drain
Silicone Endo Drain 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-04710961935803 | 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 196ca7ee-38e4-4952-bdfa-bd293d2c4633 61 fields · synced Jul 17, 2026
- EUDAMED 9c16a7d1-609e-4b35-b86b-017c05d81284 61 fields · synced May 17, 2026
- EUDAMED 0eab05a8-eab9-4fc2-8548-6b026eaab301 61 fields · synced May 17, 2026
- EUDAMED c55f917c-0682-4585-9f25-7763c02d4355 61 fields · synced May 17, 2026
- EUDAMED 1ea33aa7-5624-49e0-9804-f149cef3d0da 61 fields · synced May 19, 2026