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ECG Roll (215mm x 25m) BIONET C. 2000/3000
EUDAMEDClass I (EU MDR)
Ref SK-BN21525/16R3Model SKYMEDRef ACC-BN21525/16R3Model Accu-Plus
Identity
- Trade Name
- ECG Roll (215mm x 25m) BIONET C. 2000/3000 EUDAMEDECG ROLL 215MM X 25M BIONET C. 2000/3000 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-BN21525/16R3 EUDAMEDAccu-Plus EUDAMEDACC-BN21525/16R3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019810490 EUDAMED09551019811022 EUDAMED
- Basic UDI-DI
- 955101981MCRP-SMPY EUDAMED955101981MCRP-APNG EUDAMED
- Direct Marketing DI
- 09551019810490 EUDAMED09551019811022 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
ECG Roll (215mm x 25m) BIONET C. 2000/3000 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 | 955101981MCRP-SMPY | 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 (2)
- EUDAMED 79d89757-bc92-47a8-9778-234089f6c495 61 fields · synced Jul 20, 2026
- EUDAMED f7d097e4-bc28-41ef-b96c-83c9dab3eace 61 fields · synced Jul 20, 2026