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Bistos Fs130-120-30r-01
EUDAMEDClass I (EU MDR)
Ref SK-BT-130120-250R1Model SKYMEDRef ACC-BT130120/250R1Model Accu-PlusRef SK-BT130120-250R1Ref APP-BT130120-250R1Model ALPHA-PLUS
Identity
- Trade Name
- BISTOS FS130-120-30R-01 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-BT-130120-250R1 EUDAMEDAccu-Plus EUDAMEDACC-BT130120/250R1 EUDAMEDSK-BT130120-250R1 EUDAMEDALPHA-PLUS EUDAMEDAPP-BT130120-250R1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019811862 EUDAMED09551019813491 EUDAMED09551019818755 EUDAMED
- Basic UDI-DI
- 955101981MCRP-SMPY EUDAMED955101981MCRP-APNG EUDAMED955101981MCRPAPH3 EUDAMED
- Direct Marketing DI
- 09551019811862 EUDAMED09551019813491 EUDAMED09551019818755 EUDAMED
- EMDN Code
- Z12050385 ELECTROCARDIOGRAPHS - CONSUMABLES EUDAMEDZ12059009 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
Category: Electrocardiographic lead set, reusable
Bistos Fs130-120-30r-01 by Isd Meditech Sdn. Bhd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Electrocardiographic lead set, reusable.
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- Unimed — Unimed Medical Supplies, Inc. · Class II
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 (4)
- EUDAMED 2c059fad-d942-4924-8cf4-689fd0c7bd6a 61 fields · synced Jul 27, 2026
- EUDAMED 9112e897-3b6c-45dd-bdcc-e05abe3c2c92 61 fields · synced May 19, 2026
- EUDAMED 4805847b-34fc-43ea-bfbe-702b6dd7ff1c 61 fields · synced Jun 18, 2026
- EUDAMED ba53d885-9039-4c8f-a891-7da318894a46 61 fields · synced Jul 21, 2026