Sereny™ Hemostasis Introducer
EUDAMEDClass IIa (EU MDR)
Identity
- Trade Name
- Sereny™ Hemostasis Introducer EUDAMED
- Device Name
- Sereny™ Hemostasis Introducer EUDAMED
- Model / Reference
- 4F, 5F, 6F, 7F, 8F EUDAMED152A0507MJ35D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06931896167512 EUDAMED
- Basic UDI-DI
- 69318961INS152SE EUDAMED
- EMDN Code
- C0502 CARDIOVASCULAR INTRODUCER SHEATHS, VALVED EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
Yes
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
Yes
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Category: Vascular catheter introduction set, nonimplantable
The Sereny Hemostasis Introducer is a medical device designed for the placement of hemostasis introducers in surgical procedures. This Class IIa device features a sterile and disposable design, with a unique endocrine disruptor mechanism that helps to ensure blood coagulation. The device has undergone extensive testing and regulatory approval in various countries, making it a trusted solution for clinicians worldwide.
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Also classified as Vascular catheter introduction set, nonimplantable.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69318961INS152SE | Class IIa | Active |
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Manufacturer
- Manufacturer
- APT Medical Inc.
- EUDAMED SRN
- CN-MF-000009046
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED e0af678a-8e34-4931-90f2-97188fbb1108 61 fields · synced Jul 12, 2026