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Fukuda Denshi Op-222te
EUDAMEDClass I (EU MDR)
Ref ACC-FD110140/142RSModel Accu-PlusRef APP-FD110140-142RSModel ALPHA-PLUS
Identity
- Trade Name
- FUKUDA DENSHI OP-222TE EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-FD110140/142RS EUDAMEDALPHA-PLUS EUDAMEDAPP-FD110140-142RS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019810834 EUDAMED09551019819547 EUDAMED
- Basic UDI-DI
- 955101981MCRP-APNG EUDAMED955101981MCRPAPH3 EUDAMED
- Direct Marketing DI
- 09551019810834 EUDAMED09551019819547 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-222te 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 (2)
- EUDAMED 82ae777c-80b1-48e0-8fb0-c6d14002fd7e 61 fields · synced Jul 23, 2026
- EUDAMED bb47caf6-6388-4e43-b3d7-bcd869634bae 61 fields · synced Jul 23, 2026