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AuraFlex
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 327400000Model Ambu® AuraFlex
by Ambu A/S
Identity
- Trade Name
- Ambu® AuraFlex EUDAMEDAuraFlex FDA UDI
- Generic Name
- Laryngeal mask airway, single-use FDA UDI
- Device Name
- Ambu® AuraFlex EUDAMEDAmbu Auraflex U Size 2.5 FDA UDI
- Model / Reference
- Ambu® AuraFlex EUDAMED327400000 EUDAMED327250000U FDA UDI
- Description
- Ambu Auraflex U Size 2.5 FDA UDI
Identifiers
- Catalog Number
- 327250000U FDA UDI
- Primary DI / UDI-DI
- 05707480032556 EUDAMED05707480037803 FDA UDI
- Basic UDI-DI
- 570748030100800408G EUDAMED
- FDA Product Code
- CAE FDA UDI
- EMDN Code
- R01020101 LARYNGEAL MASKS, SINGLE-LUMEN EUDAMED
- GMDN Term
- Laryngeal mask airway, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5110 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Category: Laryngeal mask airway, single-use
AuraFlex by Ambu A/S — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Laryngeal mask airway, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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
- Ambu A/S
Sources (2)
- FDA UDI 0c5d639c-e362-4b6f-a01b-11bdc88e680c 36 fields · synced Jul 8, 2026
- EUDAMED df132230-ab60-4606-aaea-bcb1adc284c6 61 fields · synced Jul 8, 2026