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Anesthesia Mask
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AAM0201001Model 0-X#, 1-X#, 2-X#, 3-X#, 4-X#, 5-X#, 6-X#
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# EUDAMEDAAM0201001 EUDAMED0-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
- 06946430423245 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Anesthesia Mask by Xiamen Compower Medical Tech. Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
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 a0aa2cce-4c21-4d6c-b655-75546524632a 61 fields · synced Jun 18, 2026
- FDA UDI 0060c0d8-14d7-4e85-892d-bd137b02678c 33 fields · synced May 30, 2026