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Boya
EUDAMEDClass IIa (EU MDR)
Ref BY-GL-4Model 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-5Ref BY-MZ-12Model BY-MZ-10、BY-MZ-11、BY-MZ-12、BY-MZ-13、BY-MZ-14、BY-MZ-15、BY-MZ-16、BY-MZ-20、BY-MZ-21、BY-MZ-22、BY-MZ-23、BY-MZ-24、BY-MZ-25、BY-MZ-26Ref BY-MZ-14Ref BY-MZ-13Ref GZ-GL-4Model GZ-GL-1/GZ-GL-2/GZ-GL-3/GZ-GL-3(A)/GZ-GL-3(B)/GZ-GL-4/GZ-GL-4(A)/GZ-GL-4(B)/GZ-GL-5/GZ-GL-5(A)/GZ-GL-5(B)/GZ-GL-6/GZ-GL-7/GZ-GL-8/GZ-GL-9
Identity
- Trade Name
- BOYA EUDAMED
- Device Name
- Disposable Anaesthesia Masks 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-GL-4 EUDAMEDBY-MZ-10、BY-MZ-11、BY-MZ-12、BY-MZ-13、BY-MZ-14、BY-MZ-15、BY-MZ-16、BY-MZ-20、BY-MZ-21、BY-MZ-22、BY-MZ-23、BY-MZ-24、BY-MZ-25、BY-MZ-26 EUDAMEDBY-MZ-12 EUDAMEDBY-MZ-14 EUDAMEDBY-MZ-13 EUDAMEDGZ-GL-1/GZ-GL-2/GZ-GL-3/GZ-GL-3(A)/GZ-GL-3(B)/GZ-GL-4/GZ-GL-4(A)/GZ-GL-4(B)/GZ-GL-5/GZ-GL-5(A)/GZ-GL-5(B)/GZ-GL-6/GZ-GL-7/GZ-GL-8/GZ-GL-9 EUDAMEDGZ-GL-4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951467491075 EUDAMED06951467494038 EUDAMED06951467494052 EUDAMED06951467494045 EUDAMED06951467490214 EUDAMED
- Basic UDI-DI
- 69514674110001VX EUDAMED69514674170001XZ EUDAMED69514674120001WA EUDAMED
- EMDN Code
- R040102 ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS EUDAMEDR03010101 ANAESTHETIC FACE MASKS EUDAMEDR040101 ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS 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
EUDAMEDEUDAMED
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 (5)
- EUDAMED 035a0367-c8f2-4d64-90cd-dfea8a12aee0 61 fields · synced Sep 17, 2026
- EUDAMED 74843ac8-14d7-475b-96eb-02171819665f 61 fields · synced May 17, 2026
- EUDAMED a1f57336-729e-42f4-97a6-0567ebadeabb 61 fields · synced May 18, 2026
- EUDAMED 67187b8e-4d72-4253-ae16-a2ca81c553bd 61 fields · synced May 18, 2026
- EUDAMED 1655a9ae-671d-4c1f-b823-2f63022cfb15 61 fields · synced May 19, 2026