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NewLife Intensity 10
EUDAMEDClass IIa (EU MDR)
Ref AS099-10Ref AS099-210Ref AS099-103
by CAIRE Inc.
Identity
- Trade Name
- NewLife Intensity 10 EUDAMED
- Device Name
- NewLife Intensity 10 EUDAMED
- Model / Reference
- AS099-10 EUDAMEDAS099-210 EUDAMEDAS099-103 EUDAMED
Identifiers
- Primary DI / UDI-DI
- M766AS099100 EUDAMEDM766AS0992100 EUDAMEDM766AS0991030 EUDAMED
- Basic UDI-DI
- B-M766AS099100 EUDAMEDB-M766AS0992100 EUDAMEDB-M766AS0991030 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 10 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-M766AS099100 | 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 (3)
- EUDAMED 765e9f3e-e4a1-4d9f-b4dd-6f1c2a1d55eb 61 fields · synced Jul 30, 2026
- EUDAMED 7cc8b9ab-0f24-4eb2-af26-44a5881e10a4 61 fields · synced May 18, 2026
- EUDAMED 80fd21d2-6769-4c4d-98f6-ad8c8f11e3ea 61 fields · synced May 19, 2026