Identity
- Trade Name
- LifeSev Device EUDAMED
- Device Name
- LifeSev Device EUDAMED
- Model / Reference
- LifeSev Device EUDAMEDLS100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00199284111813 EUDAMED
- Basic UDI-DI
- 0019928LifeSevQJ EUDAMED
- EMDN Code
- R03010299 OXYGEN THERAPY MASKS AND NASAL CANNULAS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Nasal oxygen cannula, basic
LifeSev Device by Plastomold Industries Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 0019928LifeSevQJ | Class I | Active |
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Manufacturer
- Manufacturer
- Plastomold Industries Ltd
- EUDAMED SRN
- IL-MF-000049503
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (1)
- EUDAMED ae8574bb-20b0-42d8-81c4-bb2b8997116c 61 fields · synced Jul 17, 2026