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AcQCross Qx Integrated Transseptal Dilator/Needle
EUDAMEDClass III (EU MDR)
Ref 900306Ref 900303Ref 900301Ref 900308Ref 900309
Identity
- Trade Name
- AcQCross Qx Integrated Transseptal Dilator/Needle EUDAMED
- Device Name
- AcQCross Qx Integrated Transseptal Dilator/Needle EUDAMED
- Model / Reference
- 900306 EUDAMED900303 EUDAMED900301 EUDAMED900308 EUDAMED900309 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850027837567 EUDAMED00850027837130 EUDAMED00850027837079 EUDAMED00850027837604 EUDAMED00850027837628 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
AcQCross Qx Integrated Transseptal Dilator/Needle 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 84994112-19f2-44ed-8154-ad26d8ef6422 61 fields · synced Oct 6, 2026
- EUDAMED 8525a5e3-cf4c-4543-b9d4-d93875123b18 61 fields · synced May 18, 2026
- EUDAMED fb5765c5-90a4-4a53-9500-fb0fb3fdc109 61 fields · synced May 18, 2026
- EUDAMED fc570038-0877-4c63-bb11-d0f727440bd1 61 fields · synced May 19, 2026
- EUDAMED 070f43bd-7e52-45c5-ab44-4cafb1b57da8 61 fields · synced May 19, 2026