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Nihon Kohden Fv215-30
EUDAMEDClass I (EU MDR)
Ref SK-NK-215300-1000YModel SKYMEDRef SK-NK215300-1000YRef APP-NK21530-1000YModel ALPHA-PLUS
Identity
- Trade Name
- NIHON KOHDEN FV215-30 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-NK-215300-1000Y EUDAMEDSK-NK215300-1000Y EUDAMEDALPHA-PLUS EUDAMEDAPP-NK21530-1000Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019815686 EUDAMED09551026273585 EUDAMED
- Basic UDI-DI
- 955101981MCRP-SMPY EUDAMED955102627MCRPAPFF EUDAMED
- Direct Marketing DI
- 09551019815686 EUDAMED09551026273585 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 Fv215-30 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 9ce07eaf-02d4-4c11-a373-8de50cd89b7c 61 fields · synced Jul 21, 2026
- EUDAMED 869074f9-a5fb-4992-879e-8d942926d447 61 fields · synced Jun 19, 2026
- EUDAMED 2494d307-a2b1-486c-a191-00b4e09b6f54 61 fields · synced Jul 21, 2026