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Fukuda Cardisunny 501a/501b
EUDAMEDClass I (EU MDR)
Ref SK-5030-16R3Model SKYMED
Identity
- Trade Name
- FUKUDA CARDISUNNY 501A/501B EUDAMEDFUKUDA CARDISUNY ECG ROLL (50MM X 30M) EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-5030-16R3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019815877 EUDAMED
- Basic UDI-DI
- 955101981MCRP-SMPY EUDAMED
- Direct Marketing DI
- 09551019815877 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 Cardisunny 501a/501b 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-SMPY | 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 e5589419-b2b2-4ada-ad20-ae731c431bc0 61 fields · synced Jul 18, 2026
- EUDAMED 082526df-47d4-4746-9a78-6d0fda74656a 61 fields · synced Jul 18, 2026