← Back to catalogue
801181-003
EUDAMEDClass IIa (EU MDR)
Ref 801181-003Model CT Exprès DisposablesRef 640063
Identity
- Trade Name
- CT Expres Patient Line EUDAMED
- Model / Reference
- CT Exprès Disposables EUDAMED801181-003 EUDAMED640063 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10841716103985 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
801181-003 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 (2)
- EUDAMED 9f7fcaf0-4f62-4c00-b2d2-7d7956d44f81 61 fields · synced Jul 31, 2026
- EUDAMED cb9e29b9-73b3-41b1-ac34-a8e7b67f1763 61 fields · synced Jul 31, 2026