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NIFometer
EUDAMEDFDA UDIClass I (EU MDR)
Ref 10-34003Model Negative Inspiratory Force Meter
Identity
- Trade Name
- NIFometer EUDAMEDFDA UDI
- Generic Name
- Airway pressure monitor, non-powered FDA UDI
- Device Name
- NIFometer EUDAMED
- Model / Reference
- Negative Inspiratory Force Meter EUDAMED10-34003 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 10641043340035 EUDAMEDFDA UDI
- Basic UDI-DI
- 0641043NINE EUDAMED
- 510(k) Number
- K032593 FDA UDI
- FDA Product Code
- BXR FDA UDI
- EMDN Code
- R028099 RESPIRATORY CIRCUITS AND MOUNT CATHETERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Airway pressure monitor, non-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1780 FDA UDI
- Market of Registration
- Netherlands 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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
NIFometer by Mercury Medical — Class I — 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 | 0641043NINE | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Mercury Medical
- EUDAMED SRN
- US-MF-000002015
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED e1fee5a1-17d1-4076-8872-8d6b313deb2b 61 fields · synced Jul 23, 2026
- FDA UDI aac7df8d-e8f0-4cbc-b6bb-bf53eddad735 34 fields · synced May 30, 2026