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Kenz P210x36z
EUDAMEDClass I (EU MDR)
Ref SK-K-210150-200RS1Model SKYMEDRef SK-K210150-200RS1
Identity
- Trade Name
- KENZ P210X36Z EUDAMEDKENZ SUZUKEN P210X36Z EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-K-210150-200RS1 EUDAMEDSK-K210150-200RS1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551026270775 EUDAMED
- Basic UDI-DI
- 955102627MCRP-SMMG EUDAMED
- Direct Marketing DI
- 09551026270775 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
Kenz P210x36z 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 228ea241-51cd-4321-a164-47d80dd187a1 61 fields · synced Jun 19, 2026
- EUDAMED e36c3d68-0663-4abc-89a6-a2eaaedbf0c2 61 fields · synced Jun 19, 2026