Anest mask reuse, size 2 with MAQUET
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Open Cuff Siliconee Face Mask Reusable EUDAMEDAnest mask reuse,size 2 with MAQUET FDA UDI
- Generic Name
- Anaesthesia face mask, reusable FDA UDI
- Device Name
- Reusable Silicone Mask EUDAMED
- Model / Reference
- (O) Mask EUDAMEDXAM0004 EUDAMED6694572 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07325710002407 EUDAMEDFDA UDI
- Basic UDI-DI
- 471081008RNOMAP EUDAMED
- FDA Product Code
- BSJ FDA UDI
- EMDN Code
- R03010201 AIR/OXYGEN MASKS EUDAMED
- GMDN Term
- Anaesthesia face mask, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5550 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
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, reusable
Anest mask reuse, size 2 with MAQUET by Maquet Critical Care AB — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Anaesthesia face mask, reusable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Maquet Critical Care AB
Sources (2)
- FDA UDI 91f35cd5-efd0-45a0-8faa-c6726bee0cc5 32 fields · synced Jun 19, 2026
- EUDAMED 87a6f70d-fcd1-4049-8f77-477852f9ee10 61 fields · synced Jun 19, 2026