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Nihon Kohden Fqw210-10-295
EUDAMEDClass I (EU MDR)
Ref SK-NK-210295-250SModel SKYMEDRef ACC-NK210295/250SModel Accu-PlusRef APP-NK210295-250SModel ALPHA-PLUSRef SK-NK210295-250S
Identity
- Trade Name
- NIHON KOHDEN FQW210-10-295 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-NK-210295-250S EUDAMEDAccu-Plus EUDAMEDACC-NK210295/250S EUDAMEDALPHA-PLUS EUDAMEDAPP-NK210295-250S EUDAMEDSK-NK210295-250S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551026271178 EUDAMED09551019815006 EUDAMED09551026272199 EUDAMED
- Basic UDI-DI
- 955102627MCRP-SMMG EUDAMED955101981MCRP-APNG EUDAMED955102627MCRPAPFF EUDAMED
- Direct Marketing DI
- 09551026271178 EUDAMED09551019815006 EUDAMED09551026272199 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 Fqw210-10-295 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 (4)
- EUDAMED c8a01b7e-c740-4191-a8b3-413c23b112af 61 fields · synced Sep 17, 2026
- EUDAMED ee56d3f0-a6ba-4c77-baa0-8a0dc30f9ae1 61 fields · synced May 16, 2026
- EUDAMED 3357994f-f5a9-4d17-b304-283367579c58 61 fields · synced Jul 16, 2026
- EUDAMED 8c062f9e-37ec-40f4-add5-d0b68f873e06 61 fields · synced Sep 17, 2026