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Biosys Bfm-800
EUDAMEDClass I (EU MDR)
Ref SK-BY112120-250BModel SKYMEDRef ACC-BY112120/250BModel Accu-PlusRef APP-BY112120-250BModel ALPHA-PLUS
Identity
- Trade Name
- BIOSYS BFM-800 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-BY112120-250B EUDAMEDAccu-Plus EUDAMEDACC-BY112120/250B EUDAMEDALPHA-PLUS EUDAMEDAPP-BY112120-250B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019811954 EUDAMED09551019813590 EUDAMED09551019818717 EUDAMED
- Basic UDI-DI
- 955101981MCRP-SMPY EUDAMED955101981MCRP-APNG EUDAMED955101981MCRPAPH3 EUDAMED
- Direct Marketing DI
- 09551019811954 EUDAMED09551019813590 EUDAMED09551019818717 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
Biosys Bfm-800 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
- 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 (3)
- EUDAMED 94b4d193-b8c7-49b9-af10-76c045b3fb24 61 fields · synced Oct 6, 2026
- EUDAMED 7cd085b2-9805-4e93-bf74-c9eed9322480 61 fields · synced May 17, 2026
- EUDAMED 8df1bee6-8f4d-42a8-990a-7c30b7b95e62 61 fields · synced Sep 30, 2026