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Edan Se-1201
EUDAMEDClass I (EU MDR)
Ref SK-NK-210140-142RSModel SKYMEDRef ACC-NK210140/142RSModel Accu-PlusRef APP-NK210140-142RSModel ALPHA-PLUSRef SK-NK210140-142RS
Identity
- Trade Name
- EDAN SE-1201 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-NK-210140-142RS EUDAMEDAccu-Plus EUDAMEDACC-NK210140/142RS EUDAMEDALPHA-PLUS EUDAMEDAPP-NK210140-142RS EUDAMEDSK-NK210140-142RS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551026270188 EUDAMED09551019814023 EUDAMED09551019819356 EUDAMED
- Basic UDI-DI
- 955102627MCRP-SMMG EUDAMED955101981MCRP-APNG EUDAMED955101981MCRPAPH3 EUDAMED
- Direct Marketing DI
- 09551026270188 EUDAMED09551019814023 EUDAMED09551019819356 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 Se-1201 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 (4)
- EUDAMED 969d75f4-8d8d-4b64-b1c7-946fae61bf6d 61 fields · synced Jul 29, 2026
- EUDAMED 14fddc29-fafe-49b7-8bc8-d006e506dbdf 61 fields · synced May 19, 2026
- EUDAMED 8c348e91-bd4e-4b9c-91f1-0f8d390508cd 61 fields · synced Jul 10, 2026
- EUDAMED 7492f479-22ae-46ab-8e14-a88156c12015 61 fields · synced Jul 29, 2026