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Fukuda Denshi Op-219te/063f30-H03
EUDAMEDClass I (EU MDR)
Ref SK-FC63100-300RS1Model SKYMEDRef ACC-FC63100/300RS1Model Accu-Plus
Identity
- Trade Name
- FUKUDA DENSHI OP-219TE/063F30-H03 EUDAMEDFUKUDA DENSHI OP-219TE / 063F30-H03 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-FC63100-300RS1 EUDAMEDAccu-Plus EUDAMEDACC-FC63100/300RS1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019815457 EUDAMED09551019814269 EUDAMED
- Basic UDI-DI
- 955101981MCRP-SMPY EUDAMED955101981MCRP-APNG EUDAMED
- Direct Marketing DI
- 09551019815457 EUDAMED09551019814269 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-219te/063f30-H03 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-SMPY | 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 3e7697cd-5976-4bb6-9abf-3faad0620098 61 fields · synced Oct 6, 2026
- EUDAMED 82c27729-8bd3-4907-b915-418616f667e4 61 fields · synced May 17, 2026
- EUDAMED f4685cb4-be26-4ffb-8a7d-f295b2f9602d 61 fields · synced Jul 8, 2026