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Singapore HSA registration DE0508058

Boston Scientific MANTIS™ Clips

Singapore flagSingapore·CLASS C·Boston Scientific Corporation·Registered May 03, 2023
Device classification
Device Class
CLASS C
Medical Speciality Area
Gastroenterology & Urology
Registration information
Registration Number
DE0508058
Registration Date
May 03, 2023
Change Notification Approval Date
July 01, 2024
Retention Due Date
May 02, 2026
Product description
The MANTIS Clip is intended for clip placement within the gastrointestinal (GI) tract for the purpose of: 1. Endoscopic marking 2. Hemostasis for: Mucosal/sub-mucosal defects < 3 cm, Bleeding ulcers, Arteries < 2 mm, Polyps < 1.5 cm in diameter, Diverticula in the colon; Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel; 4. As a supplemental closure method of luminal perforations < 20 mm that can be treated conservatively
Product Owner
Name
Boston Scientific Corporation
Short Name
Boston Scientific Corporation
Address
300 Boston Scientific Way, Marlborough, MA 01752-1234, UNITED STATES
Registrant
Name
BOSTON SCIENTIFIC ASIA PACIFIC PTE. LTD.
Address
9 NORTH BUONA VISTA DRIVE, THE METROPOLIS TOWER ONE, #20-01, SINGAPORE 138588
Importer
Name
BOSTON SCIENTIFIC ASIA PACIFIC PTE. LTD.
Address
9 NORTH BUONA VISTA DRIVE, THE METROPOLIS TOWER ONE, #20-01, SINGAPORE 138588
Model information
Model Name(s)
MANTIS™ Clip MANTIS™ Clip MANTIS™ Clip MANTIS™ Clip
Model Identifier(s)
M00521420 M00521421 M00521422 M00521423
About this record

Access comprehensive regulatory information for Boston Scientific MANTIS™ Clips in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508058 and owned by Boston Scientific Corporation. The device was registered on May 03, 2023.

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS C