Singapore HSA registration DE0504998
GUNZE NEOVEIL Absorbable PGA Reinforcement Material
Singapore·CLASS D·GUNZE LIMITED·Registered October 02, 2020Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- General & Plastic Surgery
Registration information
- Registration Number
- DE0504998
- Registration Date
- October 02, 2020
- Retention Due Date
- October 01, 2025
Product description
NEOVEIL sheet type is intended for reinforcing and preventing air leakage of the suturing region and stapling region. It is indicated for (a) Reinforcement for regions which do not take a long time to heal, (b) Reinforcement for regions of weak tissues in thoracic, abdominal and oral surgery, and (c) Prevention of air leakage from the lung, bronchi and diaphragm, where such prevention is difficult to perform by only using sutures or surgical staplers. NEOVEIL tube type is intended for reinforcing and preventing air leakage of the stapling region. It is indicated for (a) Reinforcement for regions which do not take a long time to heal, (b) Reinforcement for regions of weak tissues in thoracic and abdominal surgery, and (c) Prevention of air leakage from the lung, bronchi and diaphragm, where such prevention is difficult to perform by only using surgical staplers.”
Product Owner
- Name
- GUNZE LIMITED
- Short Name
- GUNZE LIMITED
- Address
- 46, Natsumegaichi, Aono, Ayabe, Kyoto 623-8513, JAPAN
Registrant
- Name
- EMMED PTE LTD
- Address
- 7030 ANG MO KIO AVENUE 5, NORTHSTAR @ AMK, SINGAPORE 569880
Importer
- Name
- EMMED PTE LTD
- Address
- 7030 Ang Mo Kio Avenue 5, SINGAPORE 569880
Model information
- Model Name(s)
- NEOVEIL, Tube Type NEOVEIL, Tube Type NEOVEIL, Sheet Type NEOVEIL, Sheet Type NEOVEIL, Sheet Type NEOVEIL, Sheet Type NEOVEIL, Sheet Type NEOVEIL, Sheet Type NEOVEIL, Sheet Type NEOVEIL, Sheet Type NEOVEIL, Sheet Type NEOVEIL, Sheet Type NEOVEIL, Sheet Type NEOVEIL, Sheet Type NEOVEIL, Sheet Type
- Model Identifier(s)
- NV-ET-M45E-2 NV-ET-M60E-2 NV-L-015G NV-L-03G NV-L-04G NV-L-05G NV-LL-015G NV-M-015G NV-M-03G NV-M-04G NV-M-05G NV-S-015G NV-S-03G NV-S-04G NV-S-05G
About this record
Access comprehensive regulatory information for GUNZE NEOVEIL Absorbable PGA Reinforcement Material in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0504998 and owned by GUNZE LIMITED. The device was registered on October 02, 2020.
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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