Identity
- Trade Name
- Zephyr Adapter EUDAMED
- Device Name
- Zephyr Adapter EUDAMED
- Model / Reference
- MD004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05061092720004 EUDAMED
- Basic UDI-DI
- 506109272MD004VE EUDAMED
- EMDN Code
- L030101 SUCTION AND IRRIGATION SURGICAL CANNULAS AND HANDPIECES, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium 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: Surgical/emergency suction cannula, non-illuminating, reusable
Zephyr Adapter by Spoke Medical limited — Class IIa — 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 | 506109272MD004VE | Class IIa | Active |
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Manufacturer
- Manufacturer
- Spoke Medical limited
- EUDAMED SRN
- UK-MF-000049693
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED fe6ecd9d-d691-4cb0-9dd5-4dfe942df40b 61 fields · synced Oct 8, 2026