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DRENTECH PUMP 100 ML SET SERBATOIO E DRENAGGIO PIATTO 3x7 MM
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 10402Model Drentech Pump Set 100 ml Flat Drainage 3x7
by Redax S.p.A.
Identity
- Trade Name
- DRENTECH PUMP 100 ML SET SERBATOIO E DRENAGGIO PIATTO 3x7 MM EUDAMEDDrentech Pump 100 ml Flat Drainage 3x7 mm FDA UDI
- Generic Name
- Closed-wound drainage kit FDA UDI
- Device Name
- Drentech Pump Set 100 ML Flat Drainage 3x7 mm EUDAMEDThe drainage system is composed of a silicone reservoir equipped with an anti-backflow valve and one or two connectors, and a drainage tube. The drainage has depth markings, graduated from the end of the perforated section: these markings facilitate accurate positioning of the drainage in the wound. The silicone drainage is biocompatible and hemocompatible (in accordance with the regulations in force). The subject product is compatible for use with gravity or suction drainage systems. The reservoir has a capacity of 100 ml. Thanks to the typical elasticity of silicone, the drainage suction power remains constant until the reservoir is completely full. The drainage system is a sterile and single-use device. FDA UDI
- Model / Reference
- Drentech Pump Set 100 ml Flat Drainage 3x7 EUDAMED10402 EUDAMEDFDA UDI
- Description
- The drainage system is composed of a silicone reservoir equipped with an anti-backflow valve and one or two connectors, and a drainage tube. The drainage has depth markings, graduated from the end of the perforated section: these markings facilitate accurate positioning of the drainage in the wound. The silicone drainage is biocompatible and hemocompatible (in accordance with the regulations in force). The subject product is compatible for use with gravity or suction drainage systems. The reservoir has a capacity of 100 ml. Thanks to the typical elasticity of silicone, the drainage suction power remains constant until the reservoir is completely full. The drainage system is a sterile and single-use device. FDA UDI
Identifiers
- Catalog Number
- 10402 FDA UDI
- Primary DI / UDI-DI
- 08034139290591 EUDAMEDFDA UDI
- Basic UDI-DI
- 803413929BELPUMPDRAIN1aJT EUDAMED
- FDA Product Code
- GCY FDA UDI
- EMDN Code
- A0601010403 FLAT AND LAMELLAR DRAINAGES EUDAMED
- GMDN Term
- Closed-wound drainage kit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4680 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
DRENTECH PUMP 100 ML SET SERBATOIO E DRENAGGIO PIATTO 3x7 MM by Redax S.p.A. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 803413929BELPUMPDRAIN1aJT | 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 13bb23e8-f44d-4f52-a86a-7428bdebe3ee 61 fields · synced Jun 18, 2026
- FDA UDI 789c80cb-8b93-4859-bc50-007e1d5f9979 36 fields · synced May 30, 2026