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Nihon Kohden Fqw50-3-100
EUDAMEDClass I (EU MDR)
Ref SK-NK-50100-300SModel SKYMEDRef ACC-NK50100/300SModel Accu-PlusRef SK-NK50100-300SRef APP-NK50100-300SModel ALPHA-PLUS
Identity
- Trade Name
- NIHON KOHDEN FQW50-3-100 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-NK-50100-300S EUDAMEDAccu-Plus EUDAMEDACC-NK50100/300S EUDAMEDSK-NK50100-300S EUDAMEDALPHA-PLUS EUDAMEDAPP-NK50100-300S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019812340 EUDAMED09551019814894 EUDAMED09551026272229 EUDAMED
- Basic UDI-DI
- 955101981MCRP-SMPY EUDAMED955101981MCRP-APNG EUDAMED955102627MCRPAPFF EUDAMED
- Direct Marketing DI
- 09551019812340 EUDAMED09551019814894 EUDAMED09551026272229 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 Fqw50-3-100 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-SMPY | 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 15555432-ec55-4e87-8985-4bdc33f90aea 61 fields · synced Oct 6, 2026
- EUDAMED d8ee0919-a131-43d4-8998-e725b5a0c7e2 61 fields · synced May 17, 2026
- EUDAMED 31719c65-6e36-471f-bd36-7d6d5729f97f 61 fields · synced Jul 11, 2026
- EUDAMED fa3b14be-4571-43b2-ac52-f16bea4e0906 61 fields · synced Jul 26, 2026