Identity
- Trade Name
- Expiratory -Breath Card EUDAMED
- Device Name
- Expiratory -Breath Card EUDAMED
- Model / Reference
- FR-M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16976093851021 EUDAMED
- Basic UDI-DI
- 697609385FRMWM EUDAMED
- Unit of Use DI
- 06976093851024 EUDAMED
- EMDN Code
- W05019099 SAMPLES COLLECTION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Denmark 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
No
EUDAMED
New Device
No
EUDAMED
Expiratory -Breath Card by Badiusen Biotechnology (Kunshan) 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 | 697609385FRMWM | Class A | Active |
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Manufacturer
- Manufacturer
- Badiusen Biotechnology (Kunshan) Co., Ltd
- EUDAMED SRN
- CN-MF-000032909
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED db451621-2c37-44d9-bb86-afcbddbe581a 61 fields · synced Jul 29, 2026