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AG100s (control unit)
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref P/N HSAG100S01 Model AG100s-E (control unit)
Identity
- Device Name
- AG100s (control unit) EUDAMED
- Model / Reference
- AG100s-E (control unit) EUDAMEDP/N HSAG100S01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-7290015409109Y EUDAMED
- Basic UDI-DI
- B-7290015409109Y EUDAMED
- EMDN Code
- R01038001 ENDOTRACHEAL TUBE CUFFS INFLATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
AG100s (control unit) by Hospitech Respiration Ltd — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180991 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K221477 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-7290015409109Y | Class IIa | Active |
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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 cef8736e-d097-448d-b702-8ef8a62af8a8 61 fields · synced Aug 2, 2026
- FDA 510(k) K180991 1 fields · synced May 18, 2026