Identity
- Trade Name
- AirSEP AS-J EUDAMED
- Device Name
- AirSEP AS-J EUDAMED
- Model / Reference
- AS105-21 EUDAMED
Identifiers
- Primary DI / UDI-DI
- M766AS105210 EUDAMED
- Basic UDI-DI
- B-M766AS105210 EUDAMED
- EMDN Code
- Z120309 MEDICAL/MEDICINAL GAS PIPELINE SYSTEMS AND RELATED ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
AirSEP AS-J by Caire Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-M766AS105210 | Class IIa | Active |
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Manufacturer
- Manufacturer
- CAIRE Inc.
- EUDAMED SRN
- US-MF-000013030
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (1)
- EUDAMED f3a08d75-76ee-4fb0-9848-9f2f4f714c01 61 fields · synced Jul 30, 2026