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Byteflies Kit Model 2
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref Byteflies Kit Model 2
by Byteflies NV
Identity
- Trade Name
- Byteflies Kit Model 2 EUDAMED
- Model / Reference
- Byteflies Kit Model 2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05430001718218 EUDAMED
- Basic UDI-DI
- 5430001718BF13000438M3 EUDAMED
- Direct Marketing DI
- 05430001718218 EUDAMED
- EMDN Code
- Z12030299 VITAL SIGNS MONITORING INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium 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: Electrical-only medical device connection cable, reusable
Byteflies Kit Model 2 by Byteflies NV — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192549 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 5430001718BF13000438M3 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Byteflies NV
- EUDAMED SRN
- BE-MF-000014680
Sources (2)
- EUDAMED 8f20e991-99bf-4cc5-abb4-5ac836d616b5 61 fields · synced Jul 17, 2026
- FDA 510(k) K192549 1 fields · synced May 18, 2026