Identity
- Trade Name
- NIHON KOHDEN RQS50-3 EUDAMEDNIHON KOHDEN ECG ROLL (50MM X 30M) EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-5030-16R3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551026271673 EUDAMED
- Basic UDI-DI
- 955102627MCRP-SMMG EUDAMED
- Direct Marketing DI
- 09551026271673 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 Rqs50-3 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 (2)
- EUDAMED c5e6aef9-d9f3-435b-9046-841694eb40dc 61 fields · synced Jun 20, 2026
- EUDAMED 9ae8958a-d6a4-4a92-8412-38a77ec6c7b0 61 fields · synced Jun 20, 2026