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Smart Drain Scanalato Ch 10
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 24710Model CATETERE TORACICO SILICONE CH 12
by Redax S.p.A.
Identity
- Trade Name
- SMART DRAIN SCANALATO CH 10 EUDAMEDSmart Drain Round Fluted Drain Fr 10 FDA UDI
- Generic Name
- Closed-wound drain, non-bioabsorbable FDA UDI
- Device Name
- CATETERE TORACICO SILICONE CH 12 EUDAMEDA sterile and single-use silicone device characterized by a drainage groove section and a round section portion. FDA UDI
- Model / Reference
- CATETERE TORACICO SILICONE CH 12 EUDAMED24710 EUDAMEDFDA UDI
- Description
- A sterile and single-use silicone device characterized by a drainage groove section and a round section portion. FDA UDI
Identifiers
- Catalog Number
- 24710 FDA UDI
- Primary DI / UDI-DI
- 08034139295176 EUDAMEDFDA UDI
- Basic UDI-DI
- 803413929DRAIN1bGH EUDAMED
- FDA Product Code
- GBX FDA UDI
- EMDN Code
- A0601010402 CYLINDRICAL OR CIRCULAR DRAINAGES (STRAIGHT AND T-SHAPED) EUDAMED
- GMDN Term
- Closed-wound drain, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA 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
Category: Biliary drain
Smart Drain Scanalato Ch 10 by Redax S.p.A. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Biliary drain.
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- Cook — COOK INCORPORATED · U
- Biliary Plastic Stent Set — Micro-Tech (Nanjing) Co., Ltd. · Class II
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 | 803413929DRAIN1bGH | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Redax S.p.A.
- EUDAMED SRN
- IT-MF-000019320
Sources (2)
- EUDAMED 3a42ca48-6938-41bd-88dd-be1cbc92ef81 61 fields · synced Jun 18, 2026
- FDA UDI 7805c2cc-5ff0-4efb-b612-bd656c294ba1 36 fields · synced May 30, 2026