← Back to catalogue
Anaesthesia Mask
EUDAMEDClass IIa (EU MDR)
Ref AN140005NSModel AN140001NS、AN140002NS、AN140003NS、AN140004NS、AN140005NS、AN140006NS、AN140045NS
Identity
- Trade Name
- Anaesthesia Mask EUDAMED
- Device Name
- Anaesthesia Mask EUDAMED
- Model / Reference
- AN140001NS、AN140002NS、AN140003NS、AN140004NS、AN140005NS、AN140006NS、AN140045NS EUDAMEDAN140005NS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09341601006550 EUDAMED
- Basic UDI-DI
- 697201396MU2ANNNNSAM001F5 EUDAMED
- EMDN Code
- R03010101 ANAESTHETIC FACE MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
Clinical & Handling
Sterile
No
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
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Multigate Co., Ltd
- EUDAMED SRN
- CN-MF-000002513
- Authorised Representative
- RFX+Care International A/S DK-AR-000001768
Sources (1)
- EUDAMED d5153e35-5d1d-4b04-8dc0-219ba772f0c3 61 fields · synced Jun 19, 2026