← Back to catalogue
Corometrics Aao 4305/Cao 4305
EUDAMEDClass I (EU MDR)
Ref APP-CO15290-150RModel ALPHA-PLUS
Identity
- Trade Name
- COROMETRICS AAO 4305/CAO 4305 EUDAMED
- Device Name
- Medical chart Recording Paper EUDAMED
- Model / Reference
- ALPHA-PLUS EUDAMEDAPP-CO15290-150R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019819158 EUDAMED
- Basic UDI-DI
- 955101981MCRPAPH3 EUDAMED
- Direct Marketing DI
- 09551019819158 EUDAMED
- EMDN Code
- Z12059009 ECG DATA MANAGEMENT SYSTEMS EUDAMED
Classification
- Device Class
- Class I 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Corometrics Aao 4305/Cao 4305 by Isd Meditech Sdn. Bhd. — 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 | 955101981MCRPAPH3 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Isd Meditech Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000043531
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 0d85e269-ce4d-44ca-8383-8fe39e897e31 61 fields · synced Jun 19, 2026