Identity
- Trade Name
- Helios EUDAMED
- Device Name
- Helios EUDAMED
- Model / Reference
- U36EU EUDAMEDU46EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- M766U36EU0 EUDAMEDM766U46EU0 EUDAMED
- Basic UDI-DI
- B-M766U36EU0 EUDAMEDB-M766U46EU0 EUDAMED
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER 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
Category: Pulmonary function analysis system, adult
Helios by Caire Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-M766U36EU0 | 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 (2)
- EUDAMED 7ea73c28-d134-4454-a5a1-eaf20e3be417 61 fields · synced Jul 21, 2026
- EUDAMED b7c5a73c-d535-43b6-a539-a52a94479b90 61 fields · synced May 18, 2026