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Anesthesia Mask
EUDAMEDClass IIa (EU MDR)
Ref Non-inflatable（Non-sterile），2Ref Inflatable（Non-sterile），1Ref Inflatable（Non-sterile），2Ref Inflatable（Non-sterile），5Ref Non-inflatable，5Ref Inflatable，0Ref Non-inflatable，0Ref Inflatable（Non-sterile），3Ref Non-inflatable，2Ref Inflatable，1Ref Inflatable，6Ref Non-inflatable（Non-sterile），1Ref Non-inflatable，6Ref Non-inflatable（Non-sterile），4
Identity
- Trade Name
- Anesthesia Mask EUDAMED
- Device Name
- Anesthesia Mask EUDAMED
- Model / Reference
- Non-inflatable（Non-sterile），2 EUDAMEDInflatable（Non-sterile），1 EUDAMEDInflatable（Non-sterile），2 EUDAMEDInflatable（Non-sterile），5 EUDAMEDNon-inflatable，5 EUDAMEDInflatable，0 EUDAMEDNon-inflatable，0 EUDAMEDInflatable（Non-sterile），3 EUDAMEDNon-inflatable，2 EUDAMEDInflatable，1 EUDAMEDInflatable，6 EUDAMEDNon-inflatable（Non-sterile），1 EUDAMEDNon-inflatable，6 EUDAMEDNon-inflatable（Non-sterile），4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944375390479 EUDAMED06944375390394 EUDAMED06944375390400 EUDAMED06944375390431 EUDAMED06944375390363 EUDAMED06944375390240 EUDAMED06944375390318 EUDAMED06944375390417 EUDAMED06944375390332 EUDAMED06944375390257 EUDAMED06944375390301 EUDAMED06944375390462 EUDAMED06944375390370 EUDAMED06944375390493 EUDAMED
- Basic UDI-DI
- B-06944375390479 EUDAMEDB-06944375390394 EUDAMEDB-06944375390400 EUDAMEDB-06944375390431 EUDAMEDB-06944375390363 EUDAMEDB-06944375390240 EUDAMEDB-06944375390318 EUDAMEDB-06944375390417 EUDAMEDB-06944375390332 EUDAMEDB-06944375390257 EUDAMEDB-06944375390301 EUDAMEDB-06944375390462 EUDAMEDB-06944375390370 EUDAMEDB-06944375390493 EUDAMED
- EMDN Code
- R03010101 ANAESTHETIC FACE MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Anaesthesia face mask, single-use
Anesthesia Mask by Zhejiang Haisheng Medical Device Co., Ltd. — Class IIa — MDD — 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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06944375390479 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zhejiang Haisheng Medical Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000026345
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (14)
- EUDAMED 22369eb6-7655-46de-8921-c951364109d3 61 fields · synced Sep 18, 2026
- EUDAMED 6a14198c-4446-4ee4-9c89-be81bc20277b 61 fields · synced May 16, 2026
- EUDAMED 0bcb51d1-2ead-4f0d-84fd-9aeaad2dafc5 61 fields · synced May 16, 2026
- EUDAMED deacc014-65f3-40a2-90e1-6068b7bd36a1 61 fields · synced May 16, 2026
- EUDAMED a06ecd2a-c73d-4cbc-8763-c7127f036384 61 fields · synced May 16, 2026
- EUDAMED 6dfcf3c0-ecbc-4bcc-a923-243898d33795 61 fields · synced May 17, 2026
- EUDAMED b5b31f04-d553-4070-a408-5d4c0ad1ec95 61 fields · synced May 17, 2026
- EUDAMED 0d5d6ced-7a01-466e-8cce-c17db4dd6a3a 61 fields · synced May 17, 2026
- EUDAMED 954c3a5f-b025-4ad5-b8d8-0dda1a072eea 61 fields · synced May 18, 2026
- EUDAMED 680066cd-3e0f-4209-a7db-c0cb733f1f77 61 fields · synced May 18, 2026
- EUDAMED 30dcb268-917c-47e8-a3f3-1245c3a55f6e 61 fields · synced May 18, 2026
- EUDAMED 91df8a2f-444f-408a-a0f6-c3b7fd3fbebd 61 fields · synced May 18, 2026
- EUDAMED 93ceb000-2f9b-4a40-90d2-b3d2bb7c0c59 61 fields · synced May 19, 2026
- EUDAMED bb99caea-1aca-40ae-a4d6-c03802e1fcb9 61 fields · synced May 19, 2026