Identity
- Trade Name
- LifeBox 50 Standard Tan EUDAMED
- Device Name
- LifeBox50 EUDAMED
- Model / Reference
- 6001006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B54160010060 EUDAMED
- Basic UDI-DI
- ++B541600HS EUDAMED
- EMDN Code
- V0480 CLINICAL USE CONTAINERS (NON-IVD) - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Slovakia 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
LifeBox 50 Standard Tan by Faretec, Inc. — Class I — 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 | ++B541600HS | Class I | Active |
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Manufacturer
- Manufacturer
- FareTec Inc
- EUDAMED SRN
- US-MF-000014693
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 8b0c0b0a-b101-42e5-94f2-248cc6d86703 61 fields · synced Jul 10, 2026