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BiWaze Cough
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 2037351818-21406510(k) K191912
by Abmrc Llc
Identity
- Trade Name
- BiWaze Cough EUDAMED
- Device Name
- BiWaze Cough EUDAMED
- Model / Reference
- 2037351818-21406 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B9652037351818214060 EUDAMED
- Basic UDI-DI
- ++B965203735181821406PD EUDAMED
- EMDN Code
- R05010301,R05010302 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
BiWaze Cough by Abmrc LLC — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191912 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++B965203735181821406PD | Class IIa | Active |
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Manufacturer
- Manufacturer
- Abmrc Llc
- EUDAMED SRN
- US-MF-000012891
- FDA Applicant
- Abmrc, LLC
- Authorised Representative
- Porta Medical UG DE-AR-000005279
Sources (2)
- EUDAMED cedab63a-011b-45fd-b80f-451c998671ff 85 fields · synced Jun 18, 2026
- FDA 510(k) K191912 1 fields · synced May 18, 2026