Identity
- Trade Name
- DBI-BreathCollector Breath Bag-10 EUDAMED
- Device Name
- Specimen collection device EUDAMED
- Model / Reference
- DBI-C-1001-14 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640255020946 EUDAMED
- Basic UDI-DI
- 764025502TD0174A EUDAMED
- EMDN Code
- W05019099 SAMPLES COLLECTION DEVICES - OTHER 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
DBI-BreathCollector Breath Bag-10 by Effectum Medical AG — 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 | 764025502TD0174A | Class A | Active |
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Manufacturer
- Manufacturer
- Effectum Medical AG
- EUDAMED SRN
- CH-MF-000012474
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED d20a9f8b-aca3-43a3-bd87-7664729ee6e8 61 fields · synced Oct 6, 2026