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Icu Tp1
EUDAMEDClass IIa (EU MDR)
Ref ICU SA22MModel ICU TP1Ref ICU SA22Ref ICU ME2
Identity
- Device Name
- ICU TP1 EUDAMED
- Model / Reference
- ICU TP1 EUDAMEDICU SA22M EUDAMEDICU SA22 EUDAMEDICU ME2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934325308579 EUDAMED06934325307275 EUDAMED06934325306995 EUDAMED
- Basic UDI-DI
- 69343253R068025M57 EUDAMED
- Direct Marketing DI
- 06934325308579 EUDAMED06934325307275 EUDAMED06934325306995 EUDAMED
- EMDN Code
- R0680 NEBULISATION AND HUMIDIFICATION SYSTEMS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Icu Tp1 by Feellife Health Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69343253R068025M57 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Feellife Health Inc.
- EUDAMED SRN
- CN-MF-000000782
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (3)
- EUDAMED e6757cb4-f61f-4f53-9fec-a620d59c141b 61 fields · synced Jul 10, 2026
- EUDAMED c4b0006d-d36b-44fe-8e7e-026a51cd4a2f 61 fields · synced May 18, 2026
- EUDAMED f36c91f1-ed91-4304-adff-6dcddc944044 61 fields · synced May 18, 2026