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Sereny™ Hemostasis Introducer
EUDAMEDClass IIa (EU MDR)
Ref 152A0410MJ35DModel 4F, 5F, 6F, 7F, 8F
Identity
- Trade Name
- Sereny™ Hemostasis Introducer EUDAMED
- Device Name
- Sereny™ Hemostasis Introducer EUDAMED
- Model / Reference
- 4F, 5F, 6F, 7F, 8F EUDAMED152A0410MJ35D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06931896166690 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
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Vascular catheter introduction set, nonimplantable
Sereny™ Hemostasis Introducer by APT Medical Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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
European Union Active
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 8ef9096c-bb89-469e-a0f9-1cd60180077c 61 fields · synced Jul 9, 2026