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Edan E1112
EUDAMEDClass I (EU MDR)
Ref ACC-21525/16R4Model Accu-PlusRef SK-21525-16R4Model SKYMED
Identity
- Trade Name
- EDAN E1112 EUDAMEDEDAN ECG ROLL (215MM X 25M) EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-21525/16R4 EUDAMEDSKYMED EUDAMEDSK-21525-16R4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019814047 EUDAMED09551019812302 EUDAMED
- Basic UDI-DI
- 955101981MCRP-APNG EUDAMED955101981MCRP-SMPY EUDAMED
- Direct Marketing DI
- 09551019814047 EUDAMED09551019812302 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
Edan E1112 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-APNG | 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 a9f9f256-bda7-4e8b-a665-0b56d8ba71f9 61 fields · synced Oct 6, 2026
- EUDAMED ddb87f19-4fa3-41ee-9322-c7aa6c19719d 61 fields · synced May 18, 2026
- EUDAMED 0e25844e-7460-43cd-9bb7-b6790c91e5d5 61 fields · synced Jun 18, 2026