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Fukuda Carisunny 503a
EUDAMEDClass I (EU MDR)
Ref SK-BM-13030-16R4Model SKYMEDRef SK-13030-16R4
Identity
- Trade Name
- FUKUDA CARISUNNY 503A EUDAMEDFUKUDA CARDISUNY ECG ROLL (130MM X 30M) EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-BM-13030-16R4 EUDAMEDSK-13030-16R4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551026270270 EUDAMED
- Basic UDI-DI
- 955102627MCRP-SMMG EUDAMED
- Direct Marketing DI
- 09551026270270 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 Carisunny 503a 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 (2)
- EUDAMED b2f0ccee-29fd-4224-bf2e-fc31461c9b44 61 fields · synced Jun 19, 2026
- EUDAMED c8c27f77-5682-45ad-b2b3-9dc4ecec9ad2 61 fields · synced Jun 14, 2026