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Siemens 9390477 E100e
EUDAMEDClass I (EU MDR)
Ref SK-SS-104100-200RSModel SKYMEDRef APP-SS104100-200RSModel ALPHA-PLUSRef SK-SS104100-300RSRef SK-SS104100-200RSRef APP-SS104100-300RS
Identity
- Trade Name
- SIEMENS 9390477 E100E EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-SS-104100-200RS EUDAMEDALPHA-PLUS EUDAMEDAPP-SS104100-200RS EUDAMEDSK-SS104100-300RS EUDAMEDSK-SS104100-200RS EUDAMEDAPP-SS104100-300RS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551026271406 EUDAMED09551026272496 EUDAMED09551019817581 EUDAMED09551026272502 EUDAMED
- Basic UDI-DI
- 955102627MCRP-SMMG EUDAMED955102627MCRPAPFF EUDAMED955101981MCRP-SMPY EUDAMED
- Direct Marketing DI
- 09551026271406 EUDAMED09551026272496 EUDAMED09551019817581 EUDAMED09551026272502 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
Siemens 9390477 E100e 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 (5)
- EUDAMED c376820c-9153-4b3f-b1bb-0c93407d5c3c 61 fields · synced Jul 27, 2026
- EUDAMED 4559e88c-a1b5-4ba9-a08d-4233d09b6689 61 fields · synced Jul 14, 2026
- EUDAMED 8f8ff7a5-50e4-413b-ba07-c7025baa50b8 61 fields · synced Jul 19, 2026
- EUDAMED 3306abe9-ca53-4264-b1e2-f99f6b7b3671 61 fields · synced Jul 25, 2026
- EUDAMED 6bf40333-5a1e-4fcd-8292-ccfea12b53e9 61 fields · synced Jul 27, 2026