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Fukuda Cardisuny 063r30-H01
EUDAMEDClass I (EU MDR)
Ref ACC-6330/16R3Model Accu-PlusRef ACC-6330/16R4
Identity
- Trade Name
- FUKUDA CARDISUNY 063R30-H01 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-6330/16R3 EUDAMEDACC-6330/16R4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019814139 EUDAMED09551019814146 EUDAMED
- Basic UDI-DI
- 955101981MCRP-APNG EUDAMED
- Direct Marketing DI
- 09551019814139 EUDAMED09551019814146 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
Fukuda Cardisuny 063r30-H01 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 | 955101981MCRP-APNG | Class I | Active |
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Manufacturer
- Manufacturer
- Isd Meditech Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000043531
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 0da13e2f-0725-4aed-bff5-65d9e4ac7a0f 61 fields · synced Jul 15, 2026
- EUDAMED d53b1800-ef54-4805-b549-870d2a2c62d4 61 fields · synced May 18, 2026