Singapore HSA registration DE0510156

PlantTec 4DryField PH System

Singapore flagSingapore·CLASS D·PlantTec Medical GmbH·Registered December 17, 2024
Device classification
Device Class
CLASS D
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0510156
Registration Date
December 17, 2024
Change Notification Approval Date
February 05, 2025
Retention Due Date
December 16, 2025
Product description
For hemostasis: 4DryField® PH is indicated if pressure, ligatures, or other conventional measures are not effective or impractical to control bleeding from arterioles, capillaries, or veins during surgery or surgical injury. For adhesion prevention: 4DryField® PH is also indicated to prevent the formation of post- operative adhesions following surgery or surgical injuries in peritoneal and pericardial cavities.
Product Owner
Short Name
PlantTec Medical GmbH
Address
Dorette-von-Stern-Str.10, 21337 Luneburg, GERMANY
Registrant
Address
116 CHANGI ROAD, WIS@CHANGI, #04-05, SINGAPORE 419718
Importer
Address
100H PASIR PANJANG ROAD, OC@PASIR PANJANG, #07-01, SINGAPORE 118524
Model information
Model Name(s)
4DFLap (4DryField PH APPLICATOR) 4DFLap (4DryField PH APPLICATOR) 4DryField PH 4DryField PH 4DryField PH 4DryField PH 4DryField PH 4DryField PH 4DryField PH 4DryField PH
Model Identifier(s)
LA0014-EU LA0038-EU SK0001-AS SK0001-EU SK0003-AS SK0003-EU SK0005-AS SK0005-EU SK0009-AS SK0009-EU
About this record

Access comprehensive regulatory information for PlantTec 4DryField PH System in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0510156 and owned by PlantTec Medical GmbH. The device was registered on December 17, 2024.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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