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Capnopharm CapnoPen® Sterile Endoscopic Nebulizer for Single Use - HSA Registration DE0510662

Access comprehensive regulatory information for Capnopharm CapnoPen® Sterile Endoscopic Nebulizer for Single Use in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0510662 and owned by Capnopharm GmbH. The device was registered on May 02, 2025.

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 C
DE0510662
Capnopharm CapnoPen® Sterile Endoscopic Nebulizer for Single Use
HSA Registration Number: DE0510662
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Product Description

The CapnoPen® is an endoscopic nebulizer for medical delivery of therapeutic substances (chemotherapy with Oxaliplatin, Cisplatin and Doxorubicin) as pressurized aerosols into body cavities. Medical indications are peritoneal surface malignancies and malignant ascites originating from ovarian, gastric, colorectal and peritoneal mesothelioma cancers.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0510662
Registration Date
May 02, 2025
Retention Due Date
May 01, 2026
Product Owner
Short Name
Capnopharm GmbH
Address
Vor dem Kreuzberg 17, 72070 Tubingen, GERMANY
Registrant
Address
10 BUKIT BATOK CRESCENT, THE SPIRE, #07-01, SINGAPORE 658079
Importer
Address
10 BUKIT BATOK CRESCENT, THE SPIRE, #07-01, SINGAPORE 658079
Model Information
Model Name(s)
CapnoPen® Sterile Endoscopic Nebulizer for Single Use
Model Identifier(s)
CP-001k