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Promepla Tubing Set for irrigation forceps for EIP 2 - HSA Registration DE0506710

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.

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CLASS B
DE0506710
Promepla Tubing Set for irrigation forceps for EIP 2
HSA Registration Number: DE0506710
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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.

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 Owner
Short Name
PROMEPLA SAM
Address
9 avenue Albert II, 98000, MONACO
Registrant
Address
25 INTERNATIONAL BUSINESS PARK, GERMAN CENTRE, #02-61/64, SINGAPORE 609916
Importer
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