Identity
- Trade Name
- AcQGuide Flex Catheter Introducer Sets EUDAMED
- Device Name
- AcQGuide Flex Catheter Introducer Set EUDAMED
- Model / Reference
- 222852 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850027837727 EUDAMED
- Basic UDI-DI
- 0850027837FLEXX7 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
AcQGuide Flex Catheter Introducer Sets 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 | 0850027837FLEXX7 | 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 (1)
- EUDAMED e85307d6-8f3a-430c-9715-74c8ffeb47db 61 fields · synced Jun 19, 2026