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ARSCI Microtools Micro-Manipulation Pipettes - HSA Registration DE0506309

Access comprehensive regulatory information for ARSCI Microtools Micro-Manipulation Pipettes in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506309 and owned by ARSCI Inc.. The device was registered on October 20, 2021.

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
DE0506309
ARSCI Microtools Micro-Manipulation Pipettes
HSA Registration Number: DE0506309
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Product Description

The Injection Pipette (or ICSI pipette) is to be used by qualified personnel during In-Vitro Fertilization (IVF) or Assisted Reproduction Technology (ART) procedures in vitro, to inject a single sperm directly into an oocyte to fertilize itโ€”commonly known as the intracytoplasmic sperm injection (ICSI) of oocytes. Intended for one-time use. The Holding Pipette is to be used by qualified personnel during In-Vitro Fertilization (IVF) or Assisted Reproduction Technology (ART) procedures in vitro, to secure the mature oocyte for when the Injection Pipette (or ICSI pipette) is utilized in the intracytoplasmic sperm injection (ICSI) of oocytes. The Holding Pipette also can help to ensure immobility of an embryo during biopsy procedures. Intended for one-time use.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0506309
Registration Date
October 20, 2021
Retention Due Date
October 19, 2025
Product Owner
Short Name
ARSCI Inc.
Address
982 Jean-Neveu, Longueuil QC J4G 2M1, CANADA
Registrant
Address
213 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #03-07, SINGAPORE 159553
Importer
Address
1003 BUKIT MERAH CENTRAL, #02-11, SINGAPORE 159836
Model Information
Model Name(s)
Holding Pipette Holding Pipette Holding Pipette Holding Pipette Holding Pipette Holding Pipette Injection Pipette Injection Pipette Injection Pipette Injection Pipette Injection Pipette Injection Pipette Injection Pipette
Model Identifier(s)
H-3001 H-3002 H-3003 H-3501 H-3502 H-3503 I-0001 I-3001 I-30NP I-3501 I-35NP PIEZO-3001 PIEZO-3501