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Braidin™
EUDAMEDClass III (EU MDR)
Ref 950604511Ref 95120851Ref 95160851Ref 95140851Ref 95100851Ref 95050851Ref 97060112Ref 950504511Ref 95080851Ref 950404511Ref 98060110Ref 97050112Ref 98180250Ref 950804511Ref 95090851Ref 950704511
Identity
- Trade Name
- Braidin™ EUDAMED
- Device Name
- Braidin™ Hemostasis Introducer EUDAMED
- Model / Reference
- 950604511 EUDAMED95120851 EUDAMED95160851 EUDAMED95140851 EUDAMED95100851 EUDAMED95050851 EUDAMED97060112 EUDAMED950504511 EUDAMED95080851 EUDAMED950404511 EUDAMED98060110 EUDAMED97050112 EUDAMED98180250 EUDAMED950804511 EUDAMED95090851 EUDAMED950704511 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949450491423 EUDAMED06949450400487 EUDAMED06949450408469 EUDAMED06949450400494 EUDAMED06949450400470 EUDAMED06949450408452 EUDAMED06949450425695 EUDAMED06949450491416 EUDAMED06949450400456 EUDAMED06949450491409 EUDAMED06949450402245 EUDAMED06949450425671 EUDAMED06949450402993 EUDAMED06949450491447 EUDAMED06949450400463 EUDAMED06949450491430 EUDAMED
- Basic UDI-DI
- B-06949450491423 EUDAMEDB-06949450400487 EUDAMEDB-06949450408469 EUDAMEDB-06949450400494 EUDAMEDB-06949450400470 EUDAMEDB-06949450408452 EUDAMEDB-06949450425695 EUDAMEDB-06949450491416 EUDAMEDB-06949450400456 EUDAMEDB-06949450491409 EUDAMEDB-06949450402245 EUDAMEDB-06949450425671 EUDAMEDB-06949450402993 EUDAMEDB-06949450491447 EUDAMEDB-06949450400463 EUDAMEDB-06949450491430 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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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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06949450491423 | 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 (16)
- EUDAMED 3dacedda-0258-4407-bb08-f51c9c2ce1cc 61 fields · synced Sep 18, 2026
- EUDAMED c62be3be-b757-4a10-996b-6f0bb1e9a3b8 61 fields · synced May 16, 2026
- EUDAMED 003f97b9-adf8-4e0f-b312-4a1778a84e95 61 fields · synced May 16, 2026
- EUDAMED 70365208-95f9-4d16-92b3-d886e78fa46a 61 fields · synced May 17, 2026
- EUDAMED ea495f21-8dd7-4f78-8d26-40a9d6a310e3 61 fields · synced May 17, 2026
- EUDAMED d8db5a1d-ace5-48e7-a662-22d1bd0822d1 61 fields · synced May 17, 2026
- EUDAMED 57271c70-b059-4ee1-adee-fd86d4f42fd7 61 fields · synced May 17, 2026
- EUDAMED 82b97dda-634a-4924-9cc8-7327751bc54c 61 fields · synced May 17, 2026
- EUDAMED 5658119b-360b-4f6f-98b3-073c9928367d 61 fields · synced May 18, 2026
- EUDAMED 724bc12e-26b4-45b9-9a7e-b861e8586496 61 fields · synced May 18, 2026
- EUDAMED 193a7522-d7ba-4f15-9314-b3316d4f632d 61 fields · synced May 18, 2026
- EUDAMED 487e6e45-79b0-4b84-ad41-e6a1c93e2ed3 61 fields · synced May 18, 2026
- EUDAMED ff0b3c78-f0db-4168-ac5f-33c211d6277c 61 fields · synced May 18, 2026
- EUDAMED b6044c47-4626-4282-becb-a902b7e093b8 61 fields · synced May 18, 2026
- EUDAMED 65186c86-6295-4970-b6ea-c54e2510a9d3 61 fields · synced May 18, 2026
- EUDAMED f6f939df-761c-4dcd-8107-3b99ef9314d1 61 fields · synced May 19, 2026