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FlexCath Cross Transseptal Solution
EUDAMEDClass III (EU MDR)
Ref 900303Ref 900306Ref 900305Ref 900307Ref 900309
Identity
- Trade Name
- FlexCath Cross Transseptal Solution EUDAMED
- Device Name
- AcQCross Qx Integrated Transseptal Dilator/Needle EUDAMED
- Model / Reference
- 900303 EUDAMED900306 EUDAMED900305 EUDAMED900307 EUDAMED900309 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850027837819 EUDAMED00850027837871 EUDAMED00850027837857 EUDAMED00850027837895 EUDAMED00850027837932 EUDAMED
- Basic UDI-DI
- 0850027837ACQCROSSP3 EUDAMED
- EMDN Code
- C01020101 CENTRAL I.V. SINGLE-LUMEN CATHETERS, PERIPHERAL ACCESS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
FlexCath Cross Transseptal Solution by Acutus Medical, Inc. — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 0850027837ACQCROSSP3 | Class III | Active |
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Manufacturer
- Manufacturer
- Acutus Medical, Inc.
- EUDAMED SRN
- US-MF-000019413
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (5)
- EUDAMED e3934218-debc-4c90-b1b8-8584bae003f5 61 fields · synced Oct 6, 2026
- EUDAMED 2f0efb61-c8d8-4751-8868-818811d3da9f 61 fields · synced May 17, 2026
- EUDAMED 42b73145-db93-4872-b110-4df3aa447e70 61 fields · synced May 17, 2026
- EUDAMED 369b665b-5638-40f8-b35f-4c85202bd35b 61 fields · synced May 19, 2026
- EUDAMED b738e719-54e6-4650-a203-1de4e91df0aa 61 fields · synced May 19, 2026