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Fukuda Denshi Op-124te
EUDAMEDClass I (EU MDR)
Ref ACC-FD5075/400SModel Accu-PlusRef SK-FD-5075-400SModel SKYMEDRef SK-FD5075-400SRef APP-FD5075-400SModel ALPHA-PLUS
Identity
- Trade Name
- FUKUDA DENSHI OP-124TE EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-FD5075/400S EUDAMEDSKYMED EUDAMEDSK-FD-5075-400S EUDAMEDSK-FD5075-400S EUDAMEDALPHA-PLUS EUDAMEDAPP-FD5075-400S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019814238 EUDAMED09551026270331 EUDAMED09551019819585 EUDAMED
- Basic UDI-DI
- 955101981MCRP-APNG EUDAMED955102627MCRP-SMMG EUDAMED955101981MCRPAPH3 EUDAMED
- Direct Marketing DI
- 09551019814238 EUDAMED09551026270331 EUDAMED09551019819585 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-124te 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 9e6fdb80-81ad-430e-a1ac-0aacfe27c43c 61 fields · synced Oct 1, 2026
- EUDAMED 2f81d1e1-0077-49fd-9a7b-d5dc3fdeb195 61 fields · synced May 18, 2026
- EUDAMED 09a8c898-9368-4855-b08d-c2e4fa896ea3 61 fields · synced Jul 9, 2026
- EUDAMED 7f514db1-8df9-440e-a6c4-0d8fee432869 61 fields · synced Oct 1, 2026