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Kenz Suzuken R183-52z-D
EUDAMEDClass I (EU MDR)
Ref ACC-K183280/200RSModel Accu-PlusRef SK-K-183280-200RSModel SKYMEDRef SK-K183280-200RS
Identity
- Trade Name
- KENZ SUZUKEN R183-52Z-D EUDAMEDKENZ R183-52Z-D EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-K183280/200RS EUDAMEDSKYMED EUDAMEDSK-K-183280-200RS EUDAMEDSK-K183280-200RS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019814603 EUDAMED09551026270751 EUDAMED
- Basic UDI-DI
- 955101981MCRP-APNG EUDAMED955102627MCRP-SMMG EUDAMED
- Direct Marketing DI
- 09551019814603 EUDAMED09551026270751 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 R183-52z-D 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 (3)
- EUDAMED b67cc459-a115-451f-ae68-b331fb74ae5c 61 fields · synced Jul 17, 2026
- EUDAMED 9eeac346-47ed-4d66-bf50-d4fb6fa147ce 61 fields · synced May 18, 2026
- EUDAMED 6536bc22-0423-4d37-b928-ae85b270cd75 61 fields · synced Jul 17, 2026