← Back to catalogue
Nihon Kohden Fv245-30
EUDAMEDClass I (EU MDR)
Ref SK-NK-245300-1000YModel SKYMEDRef SK-NK245300-1000YRef ACC-NK245300/1000YModel Accu-PlusRef APP-NK24530-1000YModel ALPHA-PLUS
Identity
- Trade Name
- NIHON KOHDEN FV245-30 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-NK-245300-1000Y EUDAMEDSK-NK245300-1000Y EUDAMEDAccu-Plus EUDAMEDACC-NK245300/1000Y EUDAMEDALPHA-PLUS EUDAMEDAPP-NK24530-1000Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019815693 EUDAMED09551019818533 EUDAMED09551026273592 EUDAMED
- Basic UDI-DI
- 955101981MCRP-SMPY EUDAMED955101981MCRP-APNG EUDAMED955102627MCRPAPFF EUDAMED
- Direct Marketing DI
- 09551019815693 EUDAMED09551019818533 EUDAMED09551026273592 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 Fv245-30 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Isd Meditech Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000043531
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (4)
- EUDAMED 22a966f0-dd1c-40fb-8b89-b69d8255a2a7 61 fields · synced Oct 6, 2026
- EUDAMED 11256f51-bb87-4840-9459-0177dd192fdf 61 fields · synced Jun 19, 2026
- EUDAMED 2e19574d-ddb2-493c-9979-a84c1adabf00 61 fields · synced Jul 10, 2026
- EUDAMED d285fa7d-7b4c-46bb-8410-43c15251594b 61 fields · synced Jul 18, 2026