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Fukuda Denshi Op-372te
EUDAMEDClass I (EU MDR)
Ref ACC-FD210300/300RSModel Accu-PlusRef SK-FD-210300-300RSModel SKYMEDRef SK-FD210300-300RSRef APP-FD210300-300RSModel ALPHA-PLUS
Identity
- Trade Name
- FUKUDA DENSHI OP-372TE EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-FD210300/300RS EUDAMEDSKYMED EUDAMEDSK-FD-210300-300RS EUDAMEDSK-FD210300-300RS EUDAMEDALPHA-PLUS EUDAMEDAPP-FD210300-300RS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019814290 EUDAMED09551026270409 EUDAMED09551019819561 EUDAMED
- Basic UDI-DI
- 955101981MCRP-APNG EUDAMED955102627MCRP-SMMG EUDAMED955101981MCRPAPH3 EUDAMED
- Direct Marketing DI
- 09551019814290 EUDAMED09551026270409 EUDAMED09551019819561 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 Denshi Op-372te 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 (4)
- EUDAMED 238f6318-4ec5-4e9f-b6a2-aab0327bfb68 61 fields · synced Jul 12, 2026
- EUDAMED 29fcb43b-ea25-47b0-b6e5-09bf62185f0b 61 fields · synced May 17, 2026
- EUDAMED 6e2f27c7-68de-436e-8654-26d3ffdc2460 61 fields · synced Jul 9, 2026
- EUDAMED 41cbf0ac-57d7-4288-81d2-6983c936d0eb 61 fields · synced Jul 12, 2026