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Hellige Marquette 2036970-001
EUDAMEDClass I (EU MDR)
Ref SK-HM-110140-200RSModel SKYMEDRef APP-HM110140-200RSModel ALPHA-PLUS
Identity
- Trade Name
- HELLIGE MARQUETTE 2036970-001 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-HM-110140-200RS EUDAMEDALPHA-PLUS EUDAMEDAPP-HM110140-200RS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551026270461 EUDAMED09551019819653 EUDAMED
- Basic UDI-DI
- 955102627MCRP-SMMG EUDAMED955101981MCRPAPH3 EUDAMED
- Direct Marketing DI
- 09551026270461 EUDAMED09551019819653 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 2036970-001 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 | 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 3587c085-80c7-4f11-86c9-f7f94501ea0f 61 fields · synced Oct 6, 2026
- EUDAMED 9e5ad46a-c007-49b0-84bb-04ba82cbcc1e 61 fields · synced Jul 18, 2026