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1MFA Air Series
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1MFA SERIES FLOWMETERS (AIR)Model 1MFA Air Series Flowmeter
Identity
- Trade Name
- 1MFA Air Series EUDAMED1MFA Flowmeters FDA UDI
- Generic Name
- Medical gas flowmeter, Thorpe tube FDA UDI
- Device Name
- 1MFA Flowmeter (AIR) EUDAMED1MFA SERIES FLOWMETERS (AIR) FDA UDI
- Model / Reference
- 1MFA Air Series Flowmeter EUDAMED1MFA SERIES FLOWMETERS (AIR) EUDAMED1MFA Series (AIR) FDA UDI
- Description
- 1MFA SERIES FLOWMETERS (AIR) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00855887006764 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00855887006764 EUDAMED
- FDA Product Code
- CAX FDA UDI
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
- GMDN Term
- Medical gas flowmeter, Thorpe tube FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.2340 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Pulmonary function analysis system, adult
1MFA Air Series by Precision Medical, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00855887006764 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Precision Medical Inc
- EUDAMED SRN
- US-MF-000008706
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 97d4648e-412b-432e-a737-74acf95a0f8c 61 fields · synced Jul 10, 2026
- FDA UDI 0c44b989-9b0d-4a44-9a95-d3107c360e7d 34 fields · synced May 30, 2026