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Reusable Anesthesia Mask
EUDAMEDClass IIa (EU MDR)
Ref AAM0503003Model 3-Z#, 4-Z#, 5-Z#
Identity
- Trade Name
- Reusable Anesthesia Mask EUDAMED
- Device Name
- Reusable anesthesia mask EUDAMED
- Model / Reference
- 3-Z#, 4-Z#, 5-Z# EUDAMEDAAM0503003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06946430425096 EUDAMED
- Basic UDI-DI
- 694643041245302N4 EUDAMED
- Direct Marketing DI
- 06946430425096 EUDAMED
- EMDN Code
- R03010101 ANAESTHETIC FACE MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
This reusable anesthesia mask is a Class IIa medical device designed for the safe and effective administration of anesthetics. It features a unique design that allows for easy self-testing, sterilization, and replacement, making it ideal for various applications.
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
- Vital Signs™ — Airlife, Inc. · Class I
- Ventlab — Ventlab Corp. · Class I
- Anesthesia mask — Henan Tuoren Medical Device Co., Ltd · Class IIa
- King Mask — Ambu A/S · Class I
- RUSCH — TELEFLEX INCORPORATED · Class I
- compower — XIAMEN COMPOWER MEDICAL TECH. CO., LTD · 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 | 694643041245302N4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Xiamen Compower Medical Tech. Co., Ltd.
- EUDAMED SRN
- CN-MF-000011703
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED e526fc56-3d5f-4f97-851c-a37a97193d33 61 fields · synced Jun 29, 2026