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Seca Ct486z
EUDAMEDClass I (EU MDR)
Ref ACC-SC210280/250RSModel Accu-PlusRef SK-SC210280-250RSModel SKYMEDRef APP-SC210280-250RSModel ALPHA-PLUS
Identity
- Trade Name
- SECA CT486Z EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-SC210280/250RS EUDAMEDSKYMED EUDAMEDSK-SC210280-250RS EUDAMEDALPHA-PLUS EUDAMEDAPP-SC210280-250RS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019815204 EUDAMED09551026271383 EUDAMED09551026272472 EUDAMED
- Basic UDI-DI
- 955101981MCRP-APNG EUDAMED955102627MCRP-SMMG EUDAMED955102627MCRPAPFF EUDAMED
- Direct Marketing DI
- 09551019815204 EUDAMED09551026271383 EUDAMED09551026272472 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
Seca Ct486z 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 4089ad94-d6b6-497f-b71c-8bb2018cc1e5 61 fields · synced Jul 30, 2026
- EUDAMED eb799d4c-32c2-4e65-8fb3-8fdd92c36b6c 61 fields · synced May 18, 2026
- EUDAMED ab91a14c-0f3c-4f78-b596-c157979c0394 61 fields · synced Jul 21, 2026