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Nihon Kohden Fqw110-3-150
EUDAMEDClass I (EU MDR)
Ref SK-NK-110150-200SModel SKYMEDRef ACC-NK110150/200SModel Accu-PlusRef SK-NK110150-200S
Identity
- Trade Name
- NIHON KOHDEN FQW110-3-150 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-NK-110150-200S EUDAMEDAccu-Plus EUDAMEDACC-NK110150/200S EUDAMEDSK-NK110150-200S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551026271093 EUDAMED09551019814948 EUDAMED
- Basic UDI-DI
- 955102627MCRP-SMMG EUDAMED955101981MCRP-APNG EUDAMED
- Direct Marketing DI
- 09551026271093 EUDAMED09551019814948 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 Fqw110-3-150 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 1f4ae26c-88e6-4143-8163-c23029db424e 61 fields · synced Sep 18, 2026
- EUDAMED c4b5a78f-2a6e-4b5e-a8b0-8a3bcf18a0a3 61 fields · synced May 18, 2026
- EUDAMED 337d36cd-5801-4e19-b398-ef634373a862 61 fields · synced Jun 18, 2026