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W.O.M. WORLD OF MEDICINE PM304 Pump - HSA Registration DE0503953

Access comprehensive regulatory information for W.O.M. WORLD OF MEDICINE PM304 Pump in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0503953 and owned by W.O.M. World of Medicine GmbH. The device was registered on December 18, 2019.

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
DE0503953
W.O.M. WORLD OF MEDICINE PM304 Pump
HSA Registration Number: DE0503953
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Product Description

The Pump is a multi-purpose fluid management system intended for use to provide distension, fluid irrigation and aspiration, and to monitor the volume differential between the irrigation fluid flowing into and out of the patient during endoscopic diagnostic and operative procedures. Specifically, the Pump is indicated for the following: Laparoscopy - Irrigation of body cavities and fluid aspiration during diagnostic and operative procedures; Arthroscopy - Distention and irrigation of knee, shoulder, hip, elbow, ankle and wrist joint cavities and fluid aspiration during diagnostic and operative procedures; Hysteroscopy - Uterine distention, fluid aspiration and monitoring of fluid deficit during diagnostic and operative procedures; Urology - Distention and irrigation of the lower and upper urinary tract, fluid aspiration and monitoring of fluid deficit during diagnostic and operative procedures.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0503953
Registration Date
December 18, 2019
Change Notification Approval Date
February 14, 2023
Retention Due Date
December 17, 2025
Product Owner
Short Name
W.O.M. World of Medicine GmbH
Address
Salzufer 8, 10587 Berlin, GERMANY
Registrant
Address
10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201
Importer
Address
10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201 10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201
Model Information
Model Name(s)
Pump Tube set for suction, single-use Tube set for suction (with 2 ports), single-use Tube set for vacuum incl. filter, 30-day use Tube set for irrigation, single-use Tube set for irrigation, reusable
Model Identifier(s)
PM304 T0502-01 T0503-01 T0504-01 T0505-01 T0506-01