← Back to catalogue
Esaote 96900 11134
EUDAMEDClass I (EU MDR)
Ref SK-EB-210150-200SModel SKYMEDRef ACC-EB210150/200SModel Accu-PlusRef SK-EB210150-200S
Identity
- Trade Name
- ESAOTE 96900 11134 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-EB-210150-200S EUDAMEDAccu-Plus EUDAMEDACC-EB210150/200S EUDAMEDSK-EB210150-200S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551026270225 EUDAMED09551019814085 EUDAMED
- Basic UDI-DI
- 955102627MCRP-SMMG EUDAMED955101981MCRP-APNG EUDAMED
- Direct Marketing DI
- 09551026270225 EUDAMED09551019814085 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 11134 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 8001f8c5-fbcc-42e9-843b-8688ff7b1a37 61 fields · synced Jul 28, 2026
- EUDAMED f1394fe2-cd4e-401c-b5bd-3186b74661cb 61 fields · synced May 18, 2026
- EUDAMED da62e726-2278-478b-8fb4-8a0ba1d8288a 61 fields · synced Jul 28, 2026