Identity
- Trade Name
- TRISMED CARDIPIA 200 EUDAMEDTRISMED CARDIPIA ECG ROLL (63MM X 30M) EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-6330-16R4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551026271444 EUDAMED
- Basic UDI-DI
- 955102627MCRP-SMMG EUDAMED
- Direct Marketing DI
- 09551026271444 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
Trismed Cardipia 200 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 589611e8-64b8-4b82-a84d-a909ab0bbf6c 61 fields · synced Oct 6, 2026
- EUDAMED cbdc4bee-e5c4-4833-a1a0-d12aceb5d83e 61 fields · synced Oct 6, 2026