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Singapore HSA registration DE0018068

Aesculap Flow40 Insufflator

Singapore flagSingapore·CLASS C·AESCULAP AG·Registered April 29, 2016
Device classification
Device Class
CLASS C
Medical Speciality Area
General & Plastic Surgery
HSA Product Code
Refer to CRPNS
HS Code
90189030
Registration information
Registration Number
DE0018068
Registration Date
April 29, 2016
Retention Due Date
April 28, 2026
Product description
The insufflator PG080/PG200 is an active medical device and is used for therapeutic and diagnostic procedures in the field of laparoscopy. For this purpose, the peritoneum is insufflated with CO2 and dilated using a trocar or Veress needle. In addition, the insufflator is used to create an CO2 environment during open or endoscopic cardiac surgeries. The CO2 environment reduces the risk of air embolism and thus the occurrence of cardiovascular and cerebral insults. In cardiac surgery, CO2 insufflation is not used to dilate blood vessels and organs. CO2 is used to improve the visibility in coronary bypass anastomosis procedures. CO2 is transported by means of a sterile tube set.
Product Owner
Name
AESCULAP AG
Short Name
Aesculap
Address
Am Aesculap-Platz, 78532 Tuttlingen, GERMANY
Registrant
Name
B. BRAUN SINGAPORE PTE LTD
Address
600 NORTH BRIDGE ROAD, PARKVIEW SQUARE, #15-05, SINGAPORE 188778
Importer
Name
B. BRAUN SINGAPORE PTE LTD
Address
600 NORTH BRIDGE ROAD, PARKVIEW SQUARE, #15-05, SINGAPORE 188778
Model information
Model Name(s)
VERESS INSUFFLATION NEEDLE 10CM VERESS INSUFFLATION NEEDLE 12CM VERESS INSUFFLATION NEEDLE 15CM SILICONE TUBE NO GAS PREHEAT FLOW40 INSUFFLATOR INSUFFLATION TUBE W/GAS PREHEATING NIST CONNECTOR F/FLOW40 HIGH-PRESS.TUBE.CENTR.SPLY NIST/DIN 3MM HIGH-PRESS.TUBE.CENTR.SPLY NIST/DIN 5M HIGH PRESSURE TUBE 1M US/DIN HIGH PRESSURE TUBE 1M US/ISO HIGH PRESSURE TUBE 1M US/PIN FLOW40 INSUFFLATOR W/INTERFACE TEGRIS
Model Identifier(s)
PG003 PG008 PG011 PG014 PG080 PG082 PG083 PG084 PG085 PG086 PG087 PG088 PG200
About this record

Access comprehensive regulatory information for Aesculap Flow40 Insufflator in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0018068 and owned by AESCULAP AG. The device was registered on April 29, 2016.

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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