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Fukuda Denshi Op-358te
EUDAMEDClass I (EU MDR)
Ref ACC-FD14530/16R3 / ACC-14530/16R3Model Accu-PlusRef SK-FD-14530-16R3Model SKYMEDRef ACC-FD14530/16R3Ref SK-FD14530-16R3Ref APP-FD14530-16R3Model ALPHA-PLUS
Identity
- Trade Name
- FUKUDA DENSHI OP-358TE EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-FD14530/16R3 / ACC-14530/16R3 EUDAMEDSKYMED EUDAMEDSK-FD-14530-16R3 EUDAMEDACC-FD14530/16R3 EUDAMEDSK-FD14530-16R3 EUDAMEDALPHA-PLUS EUDAMEDAPP-FD14530-16R3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019814276 EUDAMED09551026270386 EUDAMED09551019819554 EUDAMED
- Basic UDI-DI
- 955101981MCRP-APNG EUDAMED955102627MCRP-SMMG EUDAMED955101981MCRPAPH3 EUDAMED
- Direct Marketing DI
- 09551019814276 EUDAMED09551026270386 EUDAMED09551019819554 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-358te 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 (5)
- EUDAMED 774cb5e6-893a-41dd-9c88-831d2b9d2403 61 fields · synced Jul 15, 2026
- EUDAMED 5d63444b-c4e7-4b02-b0a5-6e4b5bf8ea60 61 fields · synced May 17, 2026
- EUDAMED 336234fb-54a1-4e99-bc47-d8cc3daa31c4 61 fields · synced Jul 9, 2026
- EUDAMED 260b1a3a-3303-4722-b28a-80a15c41290c 61 fields · synced Jul 11, 2026
- EUDAMED 2b566596-6338-448b-8a42-5442949cc146 61 fields · synced Jul 15, 2026