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FlexCath Cross Transseptal Solution
EUDAMEDFDA UDIClass III (EU MDR)
Ref 900300
Identity
- Trade Name
- FlexCath Cross Transseptal Solution EUDAMEDAcQCross Qx FDA UDI
- Generic Name
- Cardiac transseptal access electrosurgical dilator/needle FDA UDI
- Device Name
- AcQCross Qx Integrated Transseptal Dilator/Needle EUDAMEDAcQCross Qx - AG 61cm FDA UDI
- Model / Reference
- 900300 EUDAMEDFDA UDI
- Description
- AcQCross Qx - AG 61cm FDA UDI
Identifiers
- Catalog Number
- 900300 FDA UDI
- Primary DI / UDI-DI
- 00850027837758 EUDAMED00850027837086 FDA UDI
- Basic UDI-DI
- 0850027837ACQCROSSP3 EUDAMED
- FDA Product Code
- DYB FDA UDI
- EMDN Code
- C01020101 CENTRAL I.V. SINGLE-LUMEN CATHETERS, PERIPHERAL ACCESS EUDAMED
- GMDN Term
- Cardiac transseptal access electrosurgical dilator/needle 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
MR Unsafe FDA UDI
FlexCath Cross Transseptal Solution by Acutus Medical, Inc. — Class III — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 0850027837ACQCROSSP3 | 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 8915da84-f076-4921-85e8-07433213f36c 61 fields · synced Oct 5, 2026
- FDA UDI e7f9023b-2bf3-404e-8222-248fc4f5fd6f 35 fields · synced May 27, 2026