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Fukuda Denshi Op-69te
EUDAMEDClass I (EU MDR)
Ref SK-21030-16R3Model SKYMEDRef ACC-21030/16R3Model Accu-Plus
Identity
- Trade Name
- FUKUDA DENSHI OP-69TE EUDAMEDFUKUDA DENSHI ECG ROLL (210MM X 30M) EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-21030-16R3 EUDAMEDAccu-Plus EUDAMEDACC-21030/16R3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551026270393 EUDAMED09551019814283 EUDAMED
- Basic UDI-DI
- 955102627MCRP-SMMG EUDAMED955101981MCRP-APNG EUDAMED
- Direct Marketing DI
- 09551026270393 EUDAMED09551019814283 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-69te 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 (3)
- EUDAMED 14bd7066-59df-4350-8810-1d215c20e41c 61 fields · synced Jul 29, 2026
- EUDAMED f2fe88df-2a13-4549-8e19-179d2185f789 61 fields · synced May 19, 2026
- EUDAMED 9ea34097-bddf-434c-838d-bd8a2d0cd0a4 61 fields · synced Jun 14, 2026