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Gunze PELNAC - HSA Registration DE0017374

Access comprehensive regulatory information for Gunze PELNAC in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0017374 and owned by GUNZE LIMITED. The device was registered on July 28, 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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CLASS D
DE0017374
Gunze PELNAC
HSA Registration Number: DE0017374
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Product Description

is indicated for use in full-thickness skin deficit wounds including full thickness burns, traumactic skin deficit wounds, skin deficit after tumor or nevus removal and the site of skin flap harvest.

Device Classification
Device Class
CLASS D
Medical Speciality Area
General Hospital
HSA Product Code
HSAMDA00107
HS Code
90219000
Registration Information
Registration Number
DE0017374
Registration Date
July 28, 2015
Retention Due Date
July 27, 2025
Product Owner
Short Name
GUNZE
Address
46, Natsumegaichi,Aono, Ayabe, Kyoto 623-8513, JAPAN
Registrant
Address
50 BUKIT BATOK STREET 23, MIDVIEW BUILDING, #06-03, SINGAPORE 659578
Importer
Address
50 BUKIT BATOK STREET 23, MIDVIEW BUILDING, #06-03, SINGAPORE 659578
Model Information
Model Name(s)
Pelnac mesh-fortified fenestrated type Pelnac fenestrated Lelnac mesh-fortified Pelnac standard type Pelnac single layer (normal: 3mm) Pelnac single layer (thin: 1.5mm)
Model Identifier(s)
PN-D20030 PN-DR20030 PN-F20030 PN-R20030 PN-S20030 PN-S20030T