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AG Cuffil
EUDAMEDFDA UDIClass I (EU MDR)
Ref HSCUFF0041Model AG Cuffill Model HSCUFF0041 Measurement Range 0-99 cmH2O
Identity
- Trade Name
- AG Cuffill (cmH2O) FDA UDI
- Generic Name
- Endotracheal tube cuff inflator FDA UDI
- Device Name
- AG Cuffil EUDAMEDThe AG Cuffill is intended to measure and regulate the intra-cuff pressure of Endotracheal tubes, Tracheostomy tubes and Laringial Masks Aitways. FDA UDI
- Model / Reference
- AG Cuffill Model HSCUFF0041 Measurement Range 0-99 cmH2O EUDAMEDHSCUFF0041 EUDAMEDFDA UDI
- Description
- The AG Cuffill is intended to measure and regulate the intra-cuff pressure of Endotracheal tubes, Tracheostomy tubes and Laringial Masks Aitways. FDA UDI
Identifiers
- Catalog Number
- HSCUFF0041 FDA UDI
- Primary DI / UDI-DI
- 17290015409008 EUDAMED07290015409001 FDA UDI
- Basic UDI-DI
- 1729001540900TT EUDAMED
- 510(k) Number
- K122721 FDA UDI
- FDA Product Code
- BSK FDA UDI
- EMDN Code
- R01038001,V0399 EUDAMED
- GMDN Term
- Endotracheal tube cuff inflator FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5750 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
Yes
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
MR Unsafe FDA UDI
AG Cuffil by Hospitech Respiration Ltd — 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 | 1729001540900TT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hospitech Respiration Ltd.
- EUDAMED SRN
- IL-MF-000018143
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 15ae9b58-6f71-41a7-a552-5a04e13193cf 61 fields · synced Jul 11, 2026
- FDA UDI 0bcbf51d-bb17-4af1-8e3e-b457e2e24ab1 37 fields · synced May 26, 2026