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Fukuda Cardisuny 210f60-H05
EUDAMEDClass I (EU MDR)
Ref SK-FC-210150-400RSModel SKYMEDRef ACC-FC210150/400RSModel Accu-PlusRef SK-FC210150-400RS
Identity
- Trade Name
- FUKUDA CARDISUNY 210F60-H05 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-FC-210150-400RS EUDAMEDAccu-Plus EUDAMEDACC-FC210150/400RS EUDAMEDSK-FC210150-400RS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551026270300 EUDAMED09551019814207 EUDAMED
- Basic UDI-DI
- 955102627MCRP-SMMG EUDAMED955101981MCRP-APNG EUDAMED
- Direct Marketing DI
- 09551026270300 EUDAMED09551019814207 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 210f60-H05 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 | 955102627MCRP-SMMG | 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 (3)
- EUDAMED baf9045f-3a2f-45fc-99cc-b51b352be332 61 fields · synced Oct 6, 2026
- EUDAMED 9bcab427-38ff-4477-93c5-96729933a276 61 fields · synced May 19, 2026
- EUDAMED eb628956-7746-404c-9e2d-3875e3473933 61 fields · synced Jul 29, 2026