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Kenz Suzuken R80x30r-C
EUDAMEDClass I (EU MDR)
Ref ACC-8025/13R3Model Accu-PlusRef ACC-8025/13R4
Identity
- Trade Name
- KENZ SUZUKEN R80X30R-C EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-8025/13R3 EUDAMEDACC-8025/13R4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019814535 EUDAMED09551019814542 EUDAMED
- Basic UDI-DI
- 955101981MCRP-APNG EUDAMED
- Direct Marketing DI
- 09551019814535 EUDAMED09551019814542 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
Kenz Suzuken R80x30r-C 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 8f5c0c4e-f383-47fd-8ada-192a8796910a 61 fields · synced Sep 17, 2026
- EUDAMED 5111c7a4-b591-406b-a613-c897b9dac9c2 61 fields · synced May 18, 2026