Identity
- Trade Name
- VisionHEART Monitor MX-35 EUDAMED
- Device Name
- VisionHEART Monitor EUDAMED
- Model / Reference
- MX-30 EUDAMEDMX-35 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04262568860021 EUDAMED
- Basic UDI-DI
- 426256886VVLQ7 EUDAMED
- Direct Marketing DI
- 04262568860021 EUDAMED
- EMDN Code
- Z12021003 LARYNGOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Laryngoscope blade, reusable
VisionHEART Monitor MX-35 by Jiangsu Yongle Medical Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 426256886VVLQ7 | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangsu Yongle Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000037426
- Authorised Representative
- Everbiz GmbH DE-AR-000008964
Sources (1)
- EUDAMED ba1cf95e-a1da-4bd2-81f7-346c9d6ac86b 61 fields · synced Oct 6, 2026