Identity
- Trade Name
- NewLife Intensity 8 EUDAMED
- Device Name
- NewLife Intensity 8 EUDAMED
- Model / Reference
- AS094-103 EUDAMED
Identifiers
- Primary DI / UDI-DI
- M766AS094-1030 EUDAMED
- Basic UDI-DI
- B-M766AS094-1030 EUDAMED
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS 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
NewLife Intensity 8 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-M766AS094-1030 | 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 d6f4a225-92e9-4a7a-9f93-153c0eb6a481 61 fields · synced Jul 31, 2026