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Nihon Kohden Pa9100z
EUDAMEDClass I (EU MDR)
Ref SK-NK-210140-142RSModel SKYMEDRef SK-NK210140-142RS
Identity
- Trade Name
- NIHON KOHDEN PA9100Z EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-NK-210140-142RS EUDAMEDSK-NK210140-142RS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019810315 EUDAMED
- Basic UDI-DI
- 955101981MCRP-SMPY EUDAMED
- Direct Marketing DI
- 09551019810315 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 Pa9100z 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 (2)
- EUDAMED 8ec95d43-00e5-4a92-b15c-7014e954c356 61 fields · synced Jun 18, 2026
- EUDAMED 2e2f90ae-264b-4a3f-975b-c48db1344823 61 fields · synced Jun 18, 2026