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Nihon Kohden Fqs50-2-100
EUDAMEDClass I (EU MDR)
Ref ACC-NK50100/200RModel Accu-PlusRef SK-NK-50100-200RModel SKYMEDRef APP-NK50100-200RModel ALPHA-PLUSRef SK-NK50100-200R
Identity
- Trade Name
- NIHON KOHDEN FQS50-2-100 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-NK50100/200R EUDAMEDSKYMED EUDAMEDSK-NK-50100-200R EUDAMEDALPHA-PLUS EUDAMEDAPP-NK50100-200R EUDAMEDSK-NK50100-200R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019814870 EUDAMED09551026271048 EUDAMED09551026272205 EUDAMED
- Basic UDI-DI
- 955101981MCRP-APNG EUDAMED955102627MCRP-SMMG EUDAMED955102627MCRPAPFF EUDAMED
- Direct Marketing DI
- 09551019814870 EUDAMED09551026271048 EUDAMED09551026272205 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 Fqs50-2-100 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 (4)
- EUDAMED 9c55ed8c-2def-4cbc-9b5b-9c3046c12c41 61 fields · synced Sep 18, 2026
- EUDAMED 55e27647-d7c9-4e72-8bb7-d264ba500f97 61 fields · synced May 19, 2026
- EUDAMED bbfa5273-66a5-49de-bf83-860f7796e0a5 61 fields · synced Jul 10, 2026
- EUDAMED 3658b993-4335-4465-ae25-87593f525707 61 fields · synced Jul 14, 2026