Identity
- Trade Name
- BIOSYS IFM-500 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-BY120120-250B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019811961 EUDAMED
- Basic UDI-DI
- 955101981MCRP-SMPY EUDAMED
- Direct Marketing DI
- 09551019811961 EUDAMED
- EMDN Code
- Z12050385 ELECTROCARDIOGRAPHS - CONSUMABLES 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
Biosys Ifm-500 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 (1)
- EUDAMED dc23ab6a-519d-4e56-a845-1886bdb236b8 61 fields · synced Jun 19, 2026