← Back to catalogue
Fukuda Cardisuny 130f50-H02
EUDAMEDClass I (EU MDR)
Ref ACC-FC13070/666RSModel Accu-PlusRef SK-FC-13070-666RSModel SKYMEDRef SK-FC13070-666RS
Identity
- Trade Name
- FUKUDA CARDISUNY 130F50-H02 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-FC13070/666RS EUDAMEDSKYMED EUDAMEDSK-FC-13070-666RS EUDAMEDSK-FC13070-666RS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019814184 EUDAMED09551026270287 EUDAMED
- Basic UDI-DI
- 955101981MCRP-APNG EUDAMED955102627MCRP-SMMG EUDAMED
- Direct Marketing DI
- 09551019814184 EUDAMED09551026270287 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 130f50-H02 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 |
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 (3)
- EUDAMED dc4f7c42-e6e7-4f60-8b00-7f7fa97b1579 61 fields · synced Oct 6, 2026
- EUDAMED 276d3db9-5560-4be0-945c-1523511b2a22 61 fields · synced May 18, 2026
- EUDAMED 9a5a203d-2bfd-4e2b-a16c-4dd7ea770396 61 fields · synced Jul 12, 2026