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Hellige Marquette 2030887-001
EUDAMEDClass I (EU MDR)
Ref SK-HM-8090-280RSModel SKYMEDRef ACC-HM8090/280RSModel Accu-PlusRef SK-HM8090-280RS
Identity
- Trade Name
- HELLIGE MARQUETTE 2030887-001 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-HM-8090-280RS EUDAMEDAccu-Plus EUDAMEDACC-HM8090/280RS EUDAMEDSK-HM8090-280RS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019810346 EUDAMED09551019810889 EUDAMED
- Basic UDI-DI
- 955101981MCRP-SMPY EUDAMED955101981MCRP-APNG EUDAMED
- Direct Marketing DI
- 09551019810346 EUDAMED09551019810889 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 2030887-001 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 (3)
- EUDAMED fc6f8a5c-ac74-4baf-bd16-b7446f32ae49 61 fields · synced Oct 6, 2026
- EUDAMED 96f55960-3e51-42cc-b2e3-c867faef7db2 61 fields · synced May 18, 2026
- EUDAMED 7b3751e6-e194-4ce3-ba91-a1c1a5d52d5c 61 fields · synced Jul 20, 2026