Identity
- Model / Reference
- CT Exprès Disposables EUDAMED801176-003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10841716104067 EUDAMED
- Basic UDI-DI
- 08417161000012FS EUDAMED
- EMDN Code
- Z11039085 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
801176-003 by ACIST Medical Systems, Inc. — Class IIa — 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 | 08417161000012FS | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ACIST Medical Systems, Inc.
- EUDAMED SRN
- US-MF-000010784
- Authorised Representative
- ACIST Europe BV NL-AR-000002151
Sources (1)
- EUDAMED a01745da-f474-4ec5-9a0b-3b6bce78f7b9 61 fields · synced Jul 9, 2026