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Schiller 2157-035
EUDAMEDClass I (EU MDR)
Ref SK-S11494-200RS80Model SKYMEDRef SK-S11494-100RSRef ACC-S11494/200RS80Model Accu-PlusRef APP-S11494-100RSModel ALPHA-PLUSRef SCHILLER 2157-035Ref APP-S11494-200RSRef APP-S11494-200RS80
Identity
- Trade Name
- SCHILLER 2157-035 EUDAMEDSCHILLER 2157-035 (80G) EUDAMEDSCHILLER 2157-035 80G EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-S11494-200RS80 EUDAMEDSK-S11494-100RS EUDAMEDAccu-Plus EUDAMEDACC-S11494/200RS80 EUDAMEDALPHA-PLUS EUDAMEDAPP-S11494-100RS EUDAMEDSCHILLER 2157-035 EUDAMEDAPP-S11494-200RS EUDAMEDAPP-S11494-200RS80 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551026271352 EUDAMED09551019815716 EUDAMED09551019815174 EUDAMED09551026272311 EUDAMED09551026271345 EUDAMED09551026272328 EUDAMED09551026272335 EUDAMED
- Basic UDI-DI
- 955102627MCRP-SMMG EUDAMED955101981MCRP-SMPY EUDAMED955101981MCRP-APNG EUDAMED955102627MCRPAPFF EUDAMED
- Direct Marketing DI
- 09551026271352 EUDAMED09551019815716 EUDAMED09551019815174 EUDAMED09551026272311 EUDAMED09551026271345 EUDAMED09551026272328 EUDAMED09551026272335 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 2157-035 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 (9)
- EUDAMED 5070e6d4-300f-44e1-b562-54dfbfa8a5be 61 fields · synced Aug 3, 2026
- EUDAMED c1b97a02-40ae-450d-b9b7-8ddaca129448 61 fields · synced May 17, 2026
- EUDAMED 45128609-59aa-48f8-b466-13b0cee9967c 61 fields · synced May 18, 2026
- EUDAMED 4ef5ed6c-e41a-4e6b-8d38-a76af9c0b6ad 61 fields · synced Jun 20, 2026
- EUDAMED 1cb98300-29d4-4ca6-a176-81545c7f3e7d 61 fields · synced Jul 9, 2026
- EUDAMED 6084f1a2-a396-45fe-8b80-6cbae1c60947 61 fields · synced Jul 16, 2026
- EUDAMED c57fd83d-9504-42fe-b57b-9e8ac050a190 61 fields · synced Jul 22, 2026
- EUDAMED c20a1ffc-27e7-40bf-9d7c-a412873e3249 61 fields · synced Jul 26, 2026
- EUDAMED b90b1f19-334d-4d4d-a5a5-789e1ae54271 61 fields · synced Jul 30, 2026