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Nihon Kohden Rqs145-6a-300
EUDAMEDClass I (EU MDR)
Ref SK-NK-14560-16RS3Model SKYMEDRef ACC-NK14560/16RS3Model Accu-PlusRef SK-NK14560-16RS3
Identity
- Trade Name
- NIHON KOHDEN RQS145-6A-300 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-NK-14560-16RS3 EUDAMEDAccu-Plus EUDAMEDACC-NK14560/16RS3 EUDAMEDSK-NK14560-16RS3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551026271123 EUDAMED09551019814979 EUDAMED
- Basic UDI-DI
- 955102627MCRP-SMMG EUDAMED955101981MCRP-APNG EUDAMED
- Direct Marketing DI
- 09551026271123 EUDAMED09551019814979 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
Nihon Kohden Rqs145-6a-300 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 | 955102627MCRP-SMMG | 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 e8462aab-41ec-4864-a541-f85e1cf3bb94 61 fields · synced Sep 17, 2026
- EUDAMED 271259ca-87f1-4bbf-92f8-ca0274779642 61 fields · synced May 17, 2026
- EUDAMED ad162de5-3626-409b-8ca4-334788316c0e 61 fields · synced Sep 17, 2026