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Fukuda Denshi Op-122te
EUDAMEDClass I (EU MDR)
Ref ACC-FD6375/400RSModel Accu-PlusRef SK-FD-6375-400RSModel SKYMEDRef SK-FD6375-400RSRef APP-FD6375-400RSModel ALPHA-PLUS
Identity
- Trade Name
- FUKUDA DENSHI OP-122TE EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-FD6375/400RS EUDAMEDSKYMED EUDAMEDSK-FD-6375-400RS EUDAMEDSK-FD6375-400RS EUDAMEDALPHA-PLUS EUDAMEDAPP-FD6375-400RS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019814245 EUDAMED09551026270348 EUDAMED09551019819615 EUDAMED
- Basic UDI-DI
- 955101981MCRP-APNG EUDAMED955102627MCRP-SMMG EUDAMED955101981MCRPAPH3 EUDAMED
- Direct Marketing DI
- 09551019814245 EUDAMED09551026270348 EUDAMED09551019819615 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-122te 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 3ab49e2a-4048-4e4b-a628-51a4fd061290 61 fields · synced Jul 31, 2026
- EUDAMED bd99e0a8-ee05-481f-aabb-75b4dfbdb6df 61 fields · synced May 18, 2026
- EUDAMED e31e8ad5-9414-4e36-9f66-c9ffdf9a8f52 61 fields · synced Jul 9, 2026
- EUDAMED 93527b7a-89a9-47c2-922c-fd30c6b7502c 61 fields · synced Jul 31, 2026