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Nihon Kohden Fqw210-3-140
EUDAMEDClass I (EU MDR)
Ref SK-NK-210140-200SModel SKYMEDRef ACC-NK210140/200SModel Accu-PlusRef SK-NK210140-200S
Identity
- Trade Name
- NIHON KOHDEN FQW210-3-140 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-NK-210140-200S EUDAMEDAccu-Plus EUDAMEDACC-NK210140/200S EUDAMEDSK-NK210140-200S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019810308 EUDAMED09551019810841 EUDAMED
- Basic UDI-DI
- 955101981MCRP-SMPY EUDAMED955101981MCRP-APNG EUDAMED
- Direct Marketing DI
- 09551019810308 EUDAMED09551019810841 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 Fqw210-3-140 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-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 (3)
- EUDAMED c016ddff-c170-4f27-9573-e6b0d6e49e42 61 fields · synced Jul 23, 2026
- EUDAMED 0576cbde-70d2-4f1d-b478-f291a871cfc5 61 fields · synced May 16, 2026
- EUDAMED ec74dd02-bbfc-491f-9821-66a9b325fe73 61 fields · synced Jul 17, 2026