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Maxhealth
EUDAMEDClass IIa (EU MDR)
Ref BY-GL-A-1(A)Model BY-GL-A-1,BY-GL-C-1,BY-GL-1(A),BY-GL-1(B),BY-GL-1(C),BY-GL-1(D),BY-GL-1(E), BY-GL-1(F),BY-GL-A-1(A),BY-GL-A-2,BY-GL-A-2(A),BY-GL-A-3,BY-GL-A-3(A),BY-GL-A-4,BY-GL-A-4(A),BY-GL-A-5,BY-GL-A-5(A),BY-GL-C-1(A),BY-GL-C-2,BY-GL-C-2(A),BY-GL-E-1Ref BY-GL-A-4(A)Ref GZ-GL-1Model 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
- Maxhealth EUDAMED
- Model / Reference
- BY-GL-A-1,BY-GL-C-1,BY-GL-1(A),BY-GL-1(B),BY-GL-1(C),BY-GL-1(D),BY-GL-1(E), BY-GL-1(F),BY-GL-A-1(A),BY-GL-A-2,BY-GL-A-2(A),BY-GL-A-3,BY-GL-A-3(A),BY-GL-A-4,BY-GL-A-4(A),BY-GL-A-5,BY-GL-A-5(A),BY-GL-C-1(A),BY-GL-C-2,BY-GL-C-2(A),BY-GL-E-1 EUDAMEDBY-GL-A-1(A) EUDAMEDBY-GL-A-4(A) 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-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951467492232 EUDAMED06951467492256 EUDAMED06951467490177 EUDAMED
- Basic UDI-DI
- 69514674130001WM EUDAMED69514674120001WA EUDAMED
- EMDN Code
- R02010199 STANDARD BREATHING CIRCUITS - OTHER EUDAMEDR040101 ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS EUDAMED
Classification
- Device Class
- Class IIa 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
Maxhealth 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 | 69514674130001WM | 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 (3)
- EUDAMED b00feb66-855d-4123-a826-e28396f26592 61 fields · synced Jul 13, 2026
- EUDAMED 16242dde-8aa3-4efb-ae2c-a04ba1d56946 61 fields · synced May 18, 2026
- EUDAMED 1bbebb50-3cb1-4403-a08d-7793ea35c82c 61 fields · synced May 18, 2026