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Raccordo silicone CH 15
EUDAMEDFDA UDIClass I (EU MDR)
Ref 10549Model RACCORDO DRENAGGIO CH 7 - 10 LOCK
by Redax S.p.A.
Identity
- Trade Name
- Raccordo silicone CH 15 EUDAMEDConnector for silicone Fr 15 FDA UDI
- Generic Name
- Closed-wound drain connector FDA UDI
- Device Name
- RACCORDO DRENAGGIO CH 7 - 10 LOCK EUDAMEDFittinig device designed to facilitate the connection of the tubes/drainage catheters. FDA UDI
- Model / Reference
- RACCORDO DRENAGGIO CH 7 - 10 LOCK EUDAMED10549 EUDAMEDFDA UDI
- Description
- Fittinig device designed to facilitate the connection of the tubes/drainage catheters. FDA UDI
Identifiers
- Catalog Number
- 10549 FDA UDI
- Primary DI / UDI-DI
- 08034139297026 EUDAMEDFDA UDI
- Basic UDI-DI
- 803413929CONNECTOR1b45 EUDAMED
- FDA Product Code
- GCD FDA UDI
- EMDN Code
- A070199 ADAPTERS AND CONNECTORS - OTHER EUDAMED
- GMDN Term
- Closed-wound drain connector FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4200 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Raccordo silicone CH 15 by Redax S.p.A. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 803413929CONNECTOR1b45 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Redax S.p.A.
- EUDAMED SRN
- IT-MF-000019320
Sources (2)
- EUDAMED ac145275-395f-4969-ae57-0e7d5e9fd95c 61 fields · synced Jul 11, 2026
- FDA UDI ddc490a1-de73-4d35-8604-87373db11aa9 36 fields · synced May 29, 2026