Identity
- Trade Name
- Heat Sensitive Paper RQS63-3 EUDAMED
- Device Name
- Electrocardiographic recording paper, Electroencephalographic recording paper, Medical printer paper EUDAMED
- Model / Reference
- A129 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14931921810801 EUDAMED
- Basic UDI-DI
- 4931921MD10025BM EUDAMED
- EMDN Code
- Z12030285 VITAL SIGNS MONITORING INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Heat Sensitive Paper RQS63-3 by Nihon Kohden Corporation — 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 | 4931921MD10025BM | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nihon Kohden Corporation
- EUDAMED SRN
- JP-MF-000019022
- Authorised Representative
- NIHON KOHDEN EUROPE GmbH DE-AR-000010740
Sources (1)
- EUDAMED 4b1d2d65-3b8b-4a4b-9441-5386bf141c37 61 fields · synced Jul 14, 2026