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Anaesthesia Mask
EUDAMEDClass IIa (EU MDR)
Ref AN140003NSModel AN140001NS、AN140002NS、AN140003NS、AN140004NS、AN140005NS、AN140006NS、AN140045NSRef AN140004NSRef Non-inflation Anesthetic MaskModel Non-inflation Anesthetic Mask、Anesthetic Mask without Air Cushion、Inflation Free Anesthetic MaskRef AN140005NSRef Inflation Free Anesthetic MaskRef Anesthetic Mask without Air CushionRef AN140006NSRef AN140002NSRef AN140001NSRef AN140045NS
Identity
- Trade Name
- Anaesthesia Mask EUDAMED
- Device Name
- Anaesthesia Mask EUDAMED
- Model / Reference
- AN140001NS、AN140002NS、AN140003NS、AN140004NS、AN140005NS、AN140006NS、AN140045NS EUDAMEDAN140003NS EUDAMEDAN140004NS EUDAMEDNon-inflation Anesthetic Mask、Anesthetic Mask without Air Cushion、Inflation Free Anesthetic Mask EUDAMEDNon-inflation Anesthetic Mask EUDAMEDAN140005NS EUDAMEDInflation Free Anesthetic Mask EUDAMEDAnesthetic Mask without Air Cushion EUDAMEDAN140006NS EUDAMEDAN140002NS EUDAMEDAN140001NS EUDAMEDAN140045NS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972013964010 EUDAMED06972013964027 EUDAMED06972013964065 EUDAMED06972013964034 EUDAMED06972013964089 EUDAMED06972013964072 EUDAMED06972013964041 EUDAMED06972013964003 EUDAMED09341601006529 EUDAMED09341601006512 EUDAMED09341601003207 EUDAMED
- Basic UDI-DI
- 697201396MU2ANNNNSAM001F5 EUDAMED697201396MU2ASNNNSAM001KN EUDAMED
- Direct Marketing DI
- 06972013964010 EUDAMED06972013964027 EUDAMED06972013964065 EUDAMED06972013964034 EUDAMED06972013964089 EUDAMED06972013964072 EUDAMED06972013964041 EUDAMED06972013964003 EUDAMED
- EMDN Code
- R03010101 ANAESTHETIC FACE MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
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
Category: Anaesthesia face mask, single-use
Anaesthesia Mask by Multigate 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
- Resp-O2 Air Cushion Mask with Valve, Size #1, Neonate/Infant — Dynarex Corp. · Class I
- 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 | 697201396MU2ANNNNSAM001F5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Multigate Co., Ltd
- EUDAMED SRN
- CN-MF-000002513
- Authorised Representative
- RFX+Care International A/S DK-AR-000001768
Sources (19)
- EUDAMED b68375ca-d350-4a18-a6dd-d34a734d23ed 61 fields · synced Aug 3, 2026
- EUDAMED f43fb5ea-1859-494f-9a6f-7e6f7538f850 61 fields · synced May 17, 2026
- EUDAMED 64d54c46-59c6-4eb5-b337-0bac0381c2e3 61 fields · synced May 18, 2026
- EUDAMED a7cf9e6f-1d47-48bf-8e35-46c3c5dd9c75 61 fields · synced May 18, 2026
- EUDAMED 05bceb07-e6e9-487f-a75b-5c0a6d44998a 61 fields · synced May 18, 2026
- EUDAMED e3e9c3fb-f696-453b-902b-14f68e861a3f 61 fields · synced May 18, 2026
- EUDAMED c2947d11-4a31-490b-b13e-300fae25bbc0 61 fields · synced May 19, 2026
- EUDAMED 8a4bc909-1953-40d4-a2e5-22a594cba73a 61 fields · synced May 19, 2026
- EUDAMED 021ffa35-07e8-40b1-b5b1-44ebe2fdff35 61 fields · synced Jul 9, 2026
- EUDAMED a33c26f3-8bfa-4776-ae6d-e85fe9d1c815 61 fields · synced Jul 9, 2026
- EUDAMED 12024a5c-8312-4b1c-a1ae-25928e56e752 61 fields · synced Jul 11, 2026
- EUDAMED e116cd12-d485-467d-a892-abc3ef3a0f70 61 fields · synced Jul 12, 2026
- EUDAMED ba47a1c4-5d58-4b08-ba1e-7140cb664184 61 fields · synced Jul 14, 2026
- EUDAMED def347c0-279d-473e-bccd-82bbe7723843 61 fields · synced Jul 20, 2026
- EUDAMED ac42346b-d2f8-48fc-be03-c380832390b2 61 fields · synced Jul 23, 2026
- EUDAMED ca64d66f-65a7-41a0-8eb7-812a4afd19d6 61 fields · synced Jul 29, 2026
- EUDAMED ba31b98f-814c-4e18-a94a-6aed3501597e 61 fields · synced Jul 30, 2026
- EUDAMED 952e7ed7-260d-476b-8866-bcd7fa32d4b4 61 fields · synced Aug 1, 2026
- EUDAMED d10901e3-08d3-461f-9b02-6fafca6e3185 61 fields · synced Aug 3, 2026