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FlexCath Cross Transseptal Solution with Mini Sheath
EUDAMEDFDA UDIClass III (EU MDR)
Ref 012852
Identity
- Trade Name
- FlexCath Cross Transseptal Solution with Mini Sheath EUDAMEDAcQGuide Mini-S FDA UDI
- Generic Name
- Cardiac transseptal access set FDA UDI
- Device Name
- AcQGuide Mini Catheter Introducer Sets EUDAMEDAcQGuide Mini-S, 65cm - L2 with AcQCross QX FDA UDI
- Model / Reference
- 012852 EUDAMEDFDA UDI
- Description
- AcQGuide Mini-S, 65cm - L2 with AcQCross QX FDA UDI
Identifiers
- Catalog Number
- 012852 FDA UDI
- Primary DI / UDI-DI
- 00850027837703 EUDAMED00857042007500 FDA UDI
- Basic UDI-DI
- 00857042007MINIK5 EUDAMED
- FDA Product Code
- DYB FDA UDI
- EMDN Code
- C01020101 CENTRAL I.V. SINGLE-LUMEN CATHETERS, PERIPHERAL ACCESS EUDAMED
- GMDN Term
- Cardiac transseptal access set FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1340 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
FlexCath Cross Transseptal Solution with Mini Sheath by Acutus Medical, Inc. — Class III — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 00857042007MINIK5 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Acutus Medical, Inc.
- EUDAMED SRN
- US-MF-000019413
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 8e27c646-83ef-471a-a984-39d4aa9c4ddc 61 fields · synced Jun 19, 2026
- FDA UDI 9ddfac59-3206-4991-a732-c10362c8e9ab 35 fields · synced May 30, 2026