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Drentech Pump Set 100 ML Flat Drainage 3x7 mm

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 10401Model Drentech Pump Set 100 ml Flat Drainage 3x7

by Redax S.p.A.

Identity

Trade Name
Drentech Pump Set 100 ML Flat Drainage 3x7 mm EUDAMED
100 ml Bulb and JP Flat 3/4 fenestration 3 x 7 mm FDA UDI
Generic Name
Closed-wound drainage kit FDA UDI
Device Name
Drentech Pump Set 100 ML Flat Drainage 3x7 mm EUDAMED
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
Model / Reference
Drentech Pump Set 100 ml Flat Drainage 3x7 EUDAMED
10401 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
10401 FDA UDI
Primary DI / UDI-DI
08034139290584 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 EUDAMED
Class 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

Category: Closed-wound drain, non-bioabsorbable

Drentech Pump Set 100 ML Flat Drainage 3x7 mm by Redax S.p.A. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Closed-wound drain, non-bioabsorbable.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Redax S.p.A.
EUDAMED SRN
IT-MF-000019320

Sources (2)

  • EUDAMED fc4fa04b-2f3b-4a37-af70-e046abee4a89 61 fields · synced Jul 13, 2026
  • FDA UDI a5a711ba-f383-4936-8c44-2f6e42731fda 36 fields · synced May 30, 2026