Identity
- Trade Name
- BiWaze Two Step Adapter EUDAMED
- Device Name
- BiWaze Two Step Adapter EUDAMED
- Model / Reference
- BK1443 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850050136019 EUDAMED
- Basic UDI-DI
- 0850050136BK1443BM EUDAMED
- EMDN Code
- R020302 RESPIRATORY CIRCUITS ADAPTERS AND CONNECTORS EUDAMED
Classification
- Device Class
- Class I 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
Category: Straight/elbow breathing circuit connector, reusable
BiWaze Two Step Adapter by Abmrc LLC — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 0850050136BK1443BM | Class I | Active |
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Manufacturer
- Manufacturer
- Abmrc Llc
- EUDAMED SRN
- US-MF-000012891
- Authorised Representative
- Porta Medical UG DE-AR-000005279
Sources (1)
- EUDAMED e160a66a-48f3-4080-9b7a-a85338aed89d 61 fields · synced Jul 16, 2026