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Biosys Bfm-900
EUDAMEDClass I (EU MDR)
Ref SK-BY11225-16B3Model SKYMEDRef ACC-BY11225/16B3Model Accu-Plus
Identity
- Trade Name
- BIOSYS BFM-900 EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- SKYMED EUDAMEDSK-BY11225-16B3 EUDAMEDAccu-Plus EUDAMEDACC-BY11225/16B3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019811947 EUDAMED09551019813583 EUDAMED
- Basic UDI-DI
- 955101981MCRP-SMPY EUDAMED955101981MCRP-APNG EUDAMED
- Direct Marketing DI
- 09551019811947 EUDAMED09551019813583 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
Biosys Bfm-900 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 (3)
- EUDAMED 271a0a33-a94b-47b5-bae3-24f5de50996c 61 fields · synced Aug 4, 2026
- EUDAMED 581eff98-c052-402d-85cf-05efc93746d6 61 fields · synced May 19, 2026
- EUDAMED 82ddb47a-5d32-40e8-8b72-41870cd30cd4 61 fields · synced Jul 12, 2026