← Back to catalogue
Fukuda Denshi Op-115te
EUDAMEDClass I (EU MDR)
Ref SK-FD-5075-400RSModel SKYMEDRef SK-FD5075-400RSRef APP-FD5075-400RSModel ALPHA-PLUS
Identity
- Trade Name
- FUKUDA DENSHI OP-115TE EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-FD-5075-400RS EUDAMEDSK-FD5075-400RS EUDAMEDALPHA-PLUS EUDAMEDAPP-FD5075-400RS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551026270324 EUDAMED09551019819578 EUDAMED
- Basic UDI-DI
- 955102627MCRP-SMMG EUDAMED955101981MCRPAPH3 EUDAMED
- Direct Marketing DI
- 09551026270324 EUDAMED09551019819578 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
Fukuda Denshi Op-115te 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Isd Meditech Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000043531
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED 31f3266f-4274-41af-a232-b6ce2d0d8dfa 61 fields · synced Jul 11, 2026
- EUDAMED 70df98c9-557c-41b5-bb19-b5f45452f9e2 61 fields · synced Jul 10, 2026
- EUDAMED 69d0330f-ce8c-40e4-8689-c0afbd233905 61 fields · synced Jul 11, 2026