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8mfa Series Flowmeters (air)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 8MFA SERIES FLOWMETERS (AIR)Model 8MFA Air Series Flowmeter
Identity
- Trade Name
- 8MFA SERIES FLOWMETERS (AIR) EUDAMED8MFA Flowmeters FDA UDI
- Generic Name
- Medical gas flowmeter, Thorpe tube FDA UDI
- Device Name
- 8MFA Flowmeter (Air) EUDAMED8MFA SERIES FLOWMETERS (AIR) FDA UDI
- Model / Reference
- 8MFA Air Series Flowmeter EUDAMED8MFA SERIES FLOWMETERS (AIR) EUDAMED8MFA Air Series FDA UDI
- Description
- 8MFA SERIES FLOWMETERS (AIR) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00855887006801 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00855887006801 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
8mfa Series Flowmeters (air) by Precision Medical, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-00855887006801 | 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 4f56018d-4ddc-4d78-9e43-aacb802eb87d 61 fields · synced Jul 10, 2026
- FDA UDI d77a4db9-4e6f-458e-bd27-87b2b7860fa7 34 fields · synced May 30, 2026