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Schiller 2157-026
EUDAMEDClass I (EU MDR)
Ref ACC-S8070/300RSModel Accu-PlusRef SK-S8070-300RSModel SKYMEDRef APP-S8070-300RSModel ALPHA-PLUS
Identity
- Trade Name
- SCHILLER 2157-026 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-S8070/300RS EUDAMEDSKYMED EUDAMEDSK-S8070-300RS EUDAMEDALPHA-PLUS EUDAMEDAPP-S8070-300RS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019810872 EUDAMED09551019810339 EUDAMED09551026272441 EUDAMED
- Basic UDI-DI
- 955101981MCRP-APNG EUDAMED955101981MCRP-SMPY EUDAMED955102627MCRPAPFF EUDAMED
- Direct Marketing DI
- 09551019810872 EUDAMED09551019810339 EUDAMED09551026272441 EUDAMED
- EMDN Code
- Z12059009 ECG DATA MANAGEMENT SYSTEMS EUDAMEDZ12050385 ELECTROCARDIOGRAPHS - CONSUMABLES 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
Schiller 2157-026 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 7681558d-bdb9-4ece-b6ae-ea89d777eab6 61 fields · synced Jul 18, 2026
- EUDAMED 67007c8d-e292-49cd-829b-fdf2925183fe 61 fields · synced May 17, 2026
- EUDAMED fdd4d43a-ccc6-423c-9183-4834d0e78f88 61 fields · synced Jul 12, 2026