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Boya
EUDAMEDClass IIa (EU MDR)
Ref BY-3Model BY-RGB-P-1/BY-RGB-P-2/BY-RGB-P-3/BY-GL-1/BY-GL-2/ BY-GL-3/BY-GL-4/BY-GL-5/BY-1/BY-2/BY-3/BY-4/BY-5
Identity
- Trade Name
- BOYA EUDAMED
- Model / Reference
- BY-RGB-P-1/BY-RGB-P-2/BY-RGB-P-3/BY-GL-1/BY-GL-2/ BY-GL-3/BY-GL-4/BY-GL-5/BY-1/BY-2/BY-3/BY-4/BY-5 EUDAMEDBY-3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951467491112 EUDAMED
- Basic UDI-DI
- 69514674110001VX EUDAMED
- EMDN Code
- R040102 ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
Yes
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
Boya by Ningbo Boya Medical Equipment Co., Ltd — Class IIa — 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 | 69514674110001VX | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ningbo Boya Medical Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000032282
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED cd952313-578d-4a28-a483-6e797d488df2 61 fields · synced Jun 18, 2026