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Anaesthesia Masks
EUDAMEDClass IIa (EU MDR)
Ref 5401150ERef 5401340ERef 5401130ERef 5401120ERef 5401140ERef 5401330ERef 5401250ERef 5401110ERef 5401350ERef 5401360ERef 5401270E
by Medplus Inc.
Identity
- Device Name
- Anaesthesia Masks EUDAMED
- Model / Reference
- 5401150E EUDAMED5401340E EUDAMED5401130E EUDAMED5401120E EUDAMED5401140E EUDAMED5401330E EUDAMED5401250E EUDAMED5401110E EUDAMED5401350E EUDAMED5401360E EUDAMED5401270E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16943030651860 EUDAMED06943030651139 EUDAMED06943030651849 EUDAMED06943030651863 EUDAMED16943030651846 EUDAMED06943030651832 EUDAMED16943030651853 EUDAMED06943030651122 EUDAMED06943030651887 EUDAMED06943030651825 EUDAMED16943030651884 EUDAMED16943030651143 EUDAMED16943030651150 EUDAMED16943030651891 EUDAMED06943030651856 EUDAMED16943030651129 EUDAMED
- Basic UDI-DI
- B-16943030651860 EUDAMEDB-06943030651139 EUDAMEDB-06943030651849 EUDAMEDB-06943030651863 EUDAMEDB-16943030651846 EUDAMEDB-06943030651832 EUDAMEDB-16943030651853 EUDAMEDB-06943030651122 EUDAMEDB-06943030651887 EUDAMEDB-06943030651825 EUDAMEDB-16943030651884 EUDAMEDB-16943030651143 EUDAMEDB-16943030651150 EUDAMEDB-16943030651891 EUDAMEDB-06943030651856 EUDAMEDB-16943030651129 EUDAMED
- EMDN Code
- R03010101 ANAESTHETIC FACE MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMEDSpain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
Anaesthesia Masks by Medplus Inc. — 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
- 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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-16943030651860 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medplus Inc.
- EUDAMED SRN
- CN-MF-000016416
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (16)
- EUDAMED 87a04f47-979e-449c-9944-eda599606271 61 fields · synced Jul 28, 2026
- EUDAMED 01632aeb-3c9e-4b34-8007-46d798327c52 61 fields · synced May 16, 2026
- EUDAMED 88f46e33-2a4d-43da-8283-15e7ac9a060c 61 fields · synced May 16, 2026
- EUDAMED 90d28dcb-e9b4-47d6-bc94-eba9c091d16c 61 fields · synced May 16, 2026
- EUDAMED 13aa9a3e-5e69-486c-8bad-da1efd8061fc 61 fields · synced May 16, 2026
- EUDAMED d31147ab-b2c2-40dc-b53f-5bf1314ad6d6 61 fields · synced May 17, 2026
- EUDAMED 54ea3c4e-4621-45d3-889b-4373c7284dd2 61 fields · synced May 17, 2026
- EUDAMED 6e6e533a-0028-4b35-90df-21af5252dfd5 61 fields · synced May 17, 2026
- EUDAMED a9bed3d0-eded-4b3d-a331-83a89f323766 61 fields · synced May 18, 2026
- EUDAMED 3069c14d-8f01-4ed6-9eb0-db3c3303af2d 61 fields · synced May 18, 2026
- EUDAMED 23d27b6b-e9f8-42c5-9d4a-23977d25c656 61 fields · synced May 19, 2026
- EUDAMED 3b0f5106-b6bb-48da-bd9a-d442d7d6e540 61 fields · synced May 19, 2026
- EUDAMED 81029f51-900c-43d4-aabf-8de230ccc5fd 61 fields · synced May 19, 2026
- EUDAMED 27a48e94-56bc-4276-93a4-4aa007c40e1f 61 fields · synced May 19, 2026
- EUDAMED a7f7210a-e003-4e1e-ab1b-fe507604ba37 61 fields · synced May 19, 2026
- EUDAMED c4cc9d5f-2143-4b2d-9668-969580687208 61 fields · synced May 19, 2026