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Hellige Marquette 2261 6802
EUDAMEDClass I (EU MDR)
Ref SK-9030-16R3Model SKYMEDRef ACC-9030/16R3Model Accu-Plus
Identity
- Trade Name
- HELLIGE MARQUETTE 2261 6802 EUDAMEDHELLIGE MARQUETTE ECG ROLL (90MMX30M) EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-9030-16R3 EUDAMEDAccu-Plus EUDAMEDACC-9030/16R3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551026270447 EUDAMED09551019814320 EUDAMED
- Basic UDI-DI
- 955102627MCRP-SMMG EUDAMED955101981MCRP-APNG EUDAMED
- Direct Marketing DI
- 09551026270447 EUDAMED09551019814320 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
Hellige Marquette 2261 6802 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 (3)
- EUDAMED c8429431-e093-4ce1-9350-1e025027a396 61 fields · synced Oct 6, 2026
- EUDAMED 43092fa1-0857-4fdc-8f05-7ffb145c5669 61 fields · synced May 18, 2026
- EUDAMED ea843f1d-f639-44e6-8d66-409c815348f2 61 fields · synced Jun 11, 2026