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AUTO CHART PROJECTOR ACP-8(Type: EM)
EUDAMEDClass I (EU MDR)
Ref ACP-8Ref ACP-8 (Type:EM)
Identity
- Trade Name
- AUTO CHART PROJECTOR ACP-8(Type: EM) EUDAMED
- Device Name
- AUTO CHART PROJECTOR / PIXCEL CHART EUDAMED
- Model / Reference
- ACP-8 EUDAMEDACP-8 (Type:EM) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04562123289404 EUDAMED04562123289428 EUDAMED
- Basic UDI-DI
- 4560126260120U2 EUDAMED
- EMDN Code
- Z1212012001 VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
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
AUTO CHART PROJECTOR ACP-8(Type: EM) by Topcon Corporation — Class I — 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 | 4560126260120U2 | Class I | Active |
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Manufacturer
- Manufacturer
- Topcon Corporation
- EUDAMED SRN
- JP-MF-000003928
- Authorised Representative
- Topcon Europe Medical BV NL-AR-000000441
Sources (2)
- EUDAMED 955d1437-0e5a-40f1-b015-690c7d3f91b1 61 fields · synced Jul 10, 2026
- EUDAMED b6527e83-5d6b-409d-900c-f84c77ba6952 61 fields · synced May 18, 2026