Anesthesia Mask
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Anesthesia Mask EUDAMEDCompower FDA UDI
- Generic Name
- Anaesthesia face mask, single-use FDA UDI
- Device Name
- Anesthesia Mask EUDAMEDAnesthesia mask is intended to deliver anesthetic gases to patients. In addition, anesthesia masks are also used to deliver air and/or oxygen. The mask is a Non-Sterile product for single patient use. FDA UDI
- Model / Reference
- 0-X#, 1-X#, 2-X#, 3-X#, 4-X#, 5-X#, 6-X# EUDAMEDAAM0201007 EUDAMED6-X# FDA UDI
- Description
- Anesthesia mask is intended to deliver anesthetic gases to patients. In addition, anesthesia masks are also used to deliver air and/or oxygen. The mask is a Non-Sterile product for single patient use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06946430423306 EUDAMEDFDA UDI
- Basic UDI-DI
- 694643041244705NP EUDAMED
- FDA Product Code
- BSJ FDA UDI
- EMDN Code
- R03010101 ANAESTHETIC FACE MASKS EUDAMED
- GMDN Term
- Anaesthesia face mask, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5550 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Anaesthesia face mask, single-use
Anesthesia Mask by Xiamen Compower Medical Tech. Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — 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
- 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 (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 694643041244705NP | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (2)
- EUDAMED 075804dd-5d7b-496c-87ba-37aed80bd3a6 61 fields · synced Jul 15, 2026
- FDA UDI 60574803-280e-4b0c-8da7-1b453dc13ca4 33 fields · synced May 29, 2026