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Fukuda Denshi Op-119te
EUDAMEDClass I (EU MDR)
Ref SK-FD-6330-16R4Model SKYMEDRef ACC-FD6330/16R4 / ACC-6330/16R4Model Accu-PlusRef ACC-FD6330/16R4Ref SK-FD6330-16R4Ref APP-FD6330-16R4Model ALPHA-PLUS
Identity
- Trade Name
- FUKUDA DENSHI OP-119TE EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-FD-6330-16R4 EUDAMEDAccu-Plus EUDAMEDACC-FD6330/16R4 / ACC-6330/16R4 EUDAMEDACC-FD6330/16R4 EUDAMEDSK-FD6330-16R4 EUDAMEDALPHA-PLUS EUDAMEDAPP-FD6330-16R4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551026270317 EUDAMED09551019814214 EUDAMED09551019819608 EUDAMED
- Basic UDI-DI
- 955102627MCRP-SMMG EUDAMED955101981MCRP-APNG EUDAMED955101981MCRPAPH3 EUDAMED
- Direct Marketing DI
- 09551026270317 EUDAMED09551019814214 EUDAMED09551019819608 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-119te 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 | 955102627MCRP-SMMG | 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 d987e87e-4334-429e-bc88-50ae6e195cef 61 fields · synced Oct 6, 2026
- EUDAMED d52d5552-beeb-4d49-b102-83ec91d9a034 61 fields · synced May 18, 2026
- EUDAMED 5e7125e8-2dca-4429-bb26-d95b36ea12a3 61 fields · synced Jul 9, 2026
- EUDAMED c34c27da-c5a2-422e-8001-24b52cf577ad 61 fields · synced Jul 14, 2026
- EUDAMED 822cebd1-3bf4-4f99-8460-ebb25ff073a2 61 fields · synced Jul 29, 2026