Identity
- Trade Name
- Braidin™ EUDAMED
- Device Name
- Braidin™ Hemostasis Introducer EUDAMED
- Model / Reference
- 95060851 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949450400432 EUDAMED
- Basic UDI-DI
- B-06949450400432 EUDAMED
- EMDN Code
- C0502 CARDIOVASCULAR INTRODUCER SHEATHS, VALVED EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Vascular catheter introduction set, nonimplantable
Braidin™ by APT Medical Inc. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06949450400432 | Class III | 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 3f56cbf0-bd67-40f2-a4e4-7c984284bd18 61 fields · synced Jun 19, 2026