Identity
- Trade Name
- Lunsafe EUDAMED
- Device Name
- Sputum Collection Device EUDAMED
- Model / Reference
- KLM-100301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974591041121 EUDAMED
- Basic UDI-DI
- 6974591041003AU EUDAMED
- EMDN Code
- W05019003 SPUTUM COLLECTION DEVICES EUDAMED
Classification
- Device Class
- Class A EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Lunsafe by Creative Biosciences (Guangzhou) Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 6974591041003AU | Class A | Active |
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Manufacturer
- Manufacturer
- Creative Biosciences (Guangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000034058
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 099dc2f8-79da-4c78-a857-0c566075da40 61 fields · synced Jul 11, 2026