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Singapore HSA registration DE0017400

KCI CelluTome™ Epidermal Harvesting System

Singapore flagSingapore·CLASS B·KCI USA, Inc.·Registered August 12, 2015
Device classification
Device Class
CLASS B
Medical Speciality Area
General & Plastic Surgery
HSA Product Code
Refer to CRPNS
HS Code
90189030
Registration information
Registration Number
DE0017400
Registration Date
August 12, 2015
Change Notification Approval Date
October 12, 2018
Retention Due Date
August 11, 2025
Product description
The CelluTome™ Epidermal Harvesting System is intended to reproducibly cut a thin graft for autologous skin grafting.
Product Owner
Name
KCI USA, Inc.
Short Name
KCI USA, Inc.
Address
12930 IH 10 West, TX 78249, UNITED STATES
Registrant
Name
KCI MEDICAL ASIA PTE. LTD.
Address
10 ANG MO KIO STREET 65, TECHPOINT, #01-01, SINGAPORE 569059
Importer
Name
KCI MEDICAL ASIA PTE. LTD.
Address
10 ANG MO KIO STREET 65, TECHPOINT, #01-01, SINGAPORE 569059
Model information
Model Name(s)
CelluTome™ Epidermal Harvesting System- Harvester (2.5 cm) CelluTome™ Epidermal Harvesting System- Harvester (5.0 cm) CelluTome™ Epidermal Harvesting System- Control Unit and Vacuum Head
Model Identifier(s)
CT-H25 CT-H50 CT-KIT/GB
About this record

Access comprehensive regulatory information for KCI CelluTome™ Epidermal Harvesting System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0017400 and owned by KCI USA, Inc.. The device was registered on August 12, 2015.

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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