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Singapore HSA registration DE0506710

Promepla Tubing Set for irrigation forceps for EIP 2

Singapore flagSingapore·CLASS B·PROMEPLA SAM·Registered March 10, 2022
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0506710
Registration Date
March 10, 2022
Change Notification Approval Date
December 15, 2022
Retention Due Date
March 09, 2026
Product description
Irrigation tubing sets are intended to be used to irrigate a body cavity with fluid through an endoscope typically to facilitate observation of a site with an endoscope, and/or to keep clear the working channel of an endoscope or lumen of a catheter. Tubing set Art. No. 20325-011 is: • Used with Erbe Irrigation Pump EIP 2 • Used with malleable or rigid fluid containers • Connected to 3mm irrigation connections on forceps • Used with sterile water, NaCl solution (0.9 %) or Ringer’s solution Selection of the fluid container and irrigation flow is left to the discretion of the user.
Product Owner
Name
PROMEPLA SAM
Short Name
PROMEPLA SAM
Address
9 avenue Albert II, 98000, MONACO
Registrant
Name
ERBE SINGAPORE PTE. LTD.
Address
25 INTERNATIONAL BUSINESS PARK, GERMAN CENTRE, #02-61/64, SINGAPORE 609916
Importer
Name
ERBE SINGAPORE PTE. LTD.
Address
25 INTERNATIONAL BUSINESS PARK, GERMAN CENTRE, #02-55/56, SINGAPORE 609916
Model information
Model Name(s)
Tubing set for irrigation forceps for EIP 2
Model Identifier(s)
20325-011
About this record

Access comprehensive regulatory information for Promepla Tubing Set for irrigation forceps for EIP 2 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506710 and owned by PROMEPLA SAM. The device was registered on March 10, 2022.

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B