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boya
EUDAMEDClass IIa (EU MDR)
Ref BY-MZ-15Model 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-26
Identity
- Trade Name
- boya EUDAMED
- Device Name
- Disposable Anaesthesia Masks EUDAMED
- Model / Reference
- 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-26 EUDAMEDBY-MZ-15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951467494069 EUDAMED
- Basic UDI-DI
- 69514674170001XZ EUDAMED
- EMDN Code
- R03010101 ANAESTHETIC FACE MASKS 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Anaesthesia face mask, single-use
boya by Ningbo Boya Medical Equipment Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthesia face mask, single-use.
- Ventlab — Ventlab Corp. · Class I
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- Anesthesia Mask — XIAMEN COMPOWER MEDICAL TECH. CO., LTD. · Class IIa
- Vital Signs™ — Airlife, Inc. · Class I
- Ventlab — Ventlab Corp. · Class I
- Anesthesia mask — Henan Tuoren Medical Device Co., Ltd · Class IIa
- Anesthesia Mask — XIAMEN COMPOWER MEDICAL TECH. CO., LTD. · Class IIa
- King Mask — Ambu A/S · Class I
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 | 69514674170001XZ | 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 c5ad55cf-1f3b-4554-805c-d50051b9e86a 61 fields · synced Jun 19, 2026