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Esaote 96900 11000
EUDAMEDClass I (EU MDR)
Ref SK-EB-126150-170RSModel SKYMEDRef ACC-EB126150/170RSModel Accu-PlusRef SK-EB126150-170RSRef APP-EB126150-170RSModel ALPHA-PLUS
Identity
- Trade Name
- ESAOTE 96900 11000 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-EB-126150-170RS EUDAMEDAccu-Plus EUDAMEDACC-EB126150/170RS EUDAMEDSK-EB126150-170RS EUDAMEDALPHA-PLUS EUDAMEDAPP-EB126150-170RS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551026270218 EUDAMED09551019814078 EUDAMED09551019819363 EUDAMED
- Basic UDI-DI
- 955102627MCRP-SMMG EUDAMED955101981MCRP-APNG EUDAMED955101981MCRPAPH3 EUDAMED
- Direct Marketing DI
- 09551026270218 EUDAMED09551019814078 EUDAMED09551019819363 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
Esaote 96900 11000 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 (4)
- EUDAMED c584868e-418c-4ccd-8eae-a2178cb58026 61 fields · synced Jul 18, 2026
- EUDAMED 3fb77311-81eb-4f9e-8892-48402ce3e90b 61 fields · synced May 18, 2026
- EUDAMED 64989ae4-502c-4e4b-aa82-803f47adb853 61 fields · synced Jul 9, 2026
- EUDAMED d8a9c3e9-f6c7-4362-982d-b0e6e5749c3c 61 fields · synced Jul 18, 2026