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Kenz Suzuken R112-27z-C2
EUDAMEDClass I (EU MDR)
Ref ACC-K11290/300RSModel Accu-PlusRef SK-K-11290-300RSModel SKYMEDRef APP-K11290-300RSModel ALPHA-PLUSRef SK-K11290-300RS
Identity
- Trade Name
- KENZ SUZUKEN R112-27Z-C2 EUDAMEDKENZ R112-27Z EUDAMEDKENZ SUZUKEN R112-27Z EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-K11290/300RS EUDAMEDSKYMED EUDAMEDSK-K-11290-300RS EUDAMEDALPHA-PLUS EUDAMEDAPP-K11290-300RS EUDAMEDSK-K11290-300RS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019814573 EUDAMED09551026270737 EUDAMED09551019819981 EUDAMED09551019817673 EUDAMED
- Basic UDI-DI
- 955101981MCRP-APNG EUDAMED955102627MCRP-SMMG EUDAMED955101981MCRPAPH3 EUDAMED
- Direct Marketing DI
- 09551019814573 EUDAMED09551026270737 EUDAMED09551019819981 EUDAMED09551019817673 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 R112-27z-C2 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 (5)
- EUDAMED f4ee0881-281f-4afb-9c4f-babd1880e005 61 fields · synced Oct 6, 2026
- EUDAMED fae61287-39b4-4c32-a384-2dd9cb4c4b58 61 fields · synced May 16, 2026
- EUDAMED ed1cc202-4798-440f-aae7-6f93adc3ae5a 61 fields · synced Jul 9, 2026
- EUDAMED d8d16ed7-30f7-4cd8-89ad-a1e983da592f 61 fields · synced Jul 19, 2026
- EUDAMED 9fb34446-ed9e-4e37-8174-19085b1fe1be 61 fields · synced Jul 28, 2026