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Nihon Kohden Fqw110-2-140
EUDAMEDClass I (EU MDR)
Ref ACC-NK110140/200RSModel Accu-PlusRef SK-NK-110140-200RSModel SKYMEDRef APP-NK210140-215RSModel ALPHA-PLUSRef APP-NK110140-200RSRef SK-NK110140-200RSRef ACC-NK110140/150SRef ACC-NK210140/215RSRef SK-NK110140-150SRef APP-NK110140-143S
Identity
- Trade Name
- NIHON KOHDEN FQW110-2-140 EUDAMEDNIHON KOHDEN FQW210-2-140 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-NK110140/200RS EUDAMEDSKYMED EUDAMEDSK-NK-110140-200RS EUDAMEDALPHA-PLUS EUDAMEDAPP-NK210140-215RS EUDAMEDAPP-NK110140-200RS EUDAMEDSK-NK110140-200RS EUDAMEDACC-NK110140/150S EUDAMEDACC-NK210140/215RS EUDAMEDSK-NK110140-150S EUDAMEDAPP-NK110140-143S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019814931 EUDAMED09551026271086 EUDAMED09551026272168 EUDAMED09551026272106 EUDAMED09551019818212 EUDAMED09551019818229 EUDAMED09551019818069 EUDAMED09551026272076 EUDAMED
- Basic UDI-DI
- 955101981MCRP-APNG EUDAMED955102627MCRP-SMMG EUDAMED955102627MCRPAPFF EUDAMED955101981MCRP-SMPY EUDAMED
- Direct Marketing DI
- 09551019814931 EUDAMED09551026271086 EUDAMED09551026272168 EUDAMED09551026272106 EUDAMED09551019818212 EUDAMED09551019818229 EUDAMED09551019818069 EUDAMED09551026272076 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 Fqw110-2-140 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 (9)
- EUDAMED 3e230ef1-c055-47f6-a37a-7500a73200a2 61 fields · synced Aug 3, 2026
- EUDAMED ad93182f-13e8-4c65-be8f-5569a44fc4ba 61 fields · synced May 18, 2026
- EUDAMED 2de9b6b0-0a23-44ec-81a7-e4c2fcf300a2 61 fields · synced Jun 18, 2026
- EUDAMED 61b50085-6b6a-4823-a13d-87803d25c443 61 fields · synced Jun 18, 2026
- EUDAMED 6c7a908e-1a94-4c41-99a9-62c0597772e1 61 fields · synced Jul 9, 2026
- EUDAMED a9a06fcb-5a20-47de-a19e-569d2ac258a0 61 fields · synced Jul 11, 2026
- EUDAMED 5a884831-d492-4ac6-a07a-18da83f7ee7e 61 fields · synced Jul 22, 2026
- EUDAMED 279bbac1-9c85-4149-b79f-dbd7754d410c 61 fields · synced Jul 27, 2026
- EUDAMED c4d6d5d1-2211-4a0d-afad-381ce20bb5f6 61 fields · synced Aug 3, 2026