Identity
- Trade Name
- SIMEOX EUDAMEDFDA UDI
- Generic Name
- Vacuum-assisted airway secretion-clearing system FDA UDI
- Device Name
- SIMEOX_H EUDAMEDSimeox_H airway clearance device, with remote control, power supply, transport bag and user manual FDA UDI
- Model / Reference
- SIMEOX EUDAMEDFDA UDISIMEOX_H EUDAMED
- Description
- Simeox_H airway clearance device, with remote control, power supply, transport bag and user manual FDA UDI
Identifiers
- Catalog Number
- SIMEOX_H FDA UDI
- Primary DI / UDI-DI
- 36642240001604 EUDAMEDFDA UDI
- Basic UDI-DI
- B-36642240001604 EUDAMED
- FDA Product Code
- SDT FDA UDI
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
- GMDN Term
- Vacuum-assisted airway secretion-clearing system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5665 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- Not 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Pulmonary function analysis system, adult
Simeox by Physio-Assist S.a.s. — 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-36642240001604 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Physio-Assist S.a.s.
- EUDAMED SRN
- FR-MF-000002467
Sources (2)
- EUDAMED 9fed80d4-c16c-4a53-beac-a805a02bcef8 61 fields · synced Jun 19, 2026
- FDA UDI 655bdb9d-2cb2-4c2b-81e7-05cf941e3d9c 35 fields · synced May 30, 2026