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Braidin Pro
EUDAMEDClass IIa (EU MDR)
Ref 92240251Model 92180251Ref 92260651Ref 92180351Ref 92200251Ref 92220651Ref 92240651Ref 92260351Ref 92180651
Identity
- Trade Name
- Braidin Pro EUDAMED
- Device Name
- Braidin™ Pro Introducer Sheath EUDAMED
- Model / Reference
- 92180251 EUDAMED92240251 EUDAMED92260651 EUDAMED92180351 EUDAMED92200251 EUDAMED92220651 EUDAMED92240651 EUDAMED92260351 EUDAMED92180651 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06931896193290 EUDAMED06931896194259 EUDAMED06931896193610 EUDAMED06931896193252 EUDAMED06931896194211 EUDAMED06931896194235 EUDAMED06931896193238 EUDAMED06931896193696 EUDAMED06931896194174 EUDAMED
- Basic UDI-DI
- 69494504SHM92WR EUDAMED
- EMDN Code
- C0502 CARDIOVASCULAR INTRODUCER SHEATHS, VALVED EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Braidin Pro 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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- Demax — Beijing Demax Medical Technology Co., Ltd · Class II
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 | 69494504SHM92WR | 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 (9)
- EUDAMED 56da0fc0-ea1a-4f01-b9c6-52c75b95c9a2 61 fields · synced Aug 1, 2026
- EUDAMED f6082bdc-f4c7-410e-932d-8ca1cd4ba5e7 61 fields · synced May 17, 2026
- EUDAMED da0a00db-57c1-4595-ac10-8beb11726f69 61 fields · synced May 17, 2026
- EUDAMED 4e583389-8d9e-4c52-8d82-9e5b9aa0dafc 61 fields · synced May 18, 2026
- EUDAMED 43fc2e41-7a6b-4238-9dd5-10b1e956290d 61 fields · synced May 18, 2026
- EUDAMED 007e169a-e359-4629-b964-99c1407ad5fe 61 fields · synced May 18, 2026
- EUDAMED 6c585495-23ce-4bc7-ae86-f843b0005490 61 fields · synced May 18, 2026
- EUDAMED b8d2fd17-1ea1-4659-8432-87509b02bbc2 61 fields · synced May 18, 2026
- EUDAMED 7790f5a1-7543-48c3-b997-2a9c336192c0 61 fields · synced May 19, 2026