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Schiller 2157-017
EUDAMEDClass I (EU MDR)
Ref ACC-S210280/215RSModel Accu-PlusRef SK-S210280-215RSModel SKYMEDRef APP-S210280-215RSModel ALPHA-PLUS
Identity
- Trade Name
- SCHILLER 2157-017 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-S210280/215RS EUDAMEDSKYMED EUDAMEDSK-S210280-215RS EUDAMEDALPHA-PLUS EUDAMEDAPP-S210280-215RS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019815112 EUDAMED09551026271307 EUDAMED09551026272427 EUDAMED
- Basic UDI-DI
- 955101981MCRP-APNG EUDAMED955102627MCRP-SMMG EUDAMED955102627MCRPAPFF EUDAMED
- Direct Marketing DI
- 09551019815112 EUDAMED09551026271307 EUDAMED09551026272427 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
Schiller 2157-017 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 96c66261-42f1-42f9-85ec-4e8954b5fc58 61 fields · synced Oct 6, 2026
- EUDAMED 7ab1e17f-1d21-421d-a791-229f40201879 61 fields · synced May 18, 2026
- EUDAMED 51cd8df5-e695-4663-9107-9b78e8c3439d 61 fields · synced Jul 31, 2026