Identity
- Trade Name
- Zephyr EUDAMED
- Device Name
- Zephyr Sucker EUDAMED
- Model / Reference
- MD100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05061092720011 EUDAMED
- Basic UDI-DI
- 506109272MD100VB 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
Yes
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 by Spoke Medical limited — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical/emergency suction cannula, non-illuminating, reusable.
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
- Ambler Surgical — Ambler Surgical, LLC · Class II
- MicroFrance® — Integra Microfrance · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- SCANLAN® Variable Suction Rotatable Tips — SCANLAN INTERNATIONAL INC · Class I
- Fukushima Tear Drop Suction Tube Straight Malleable 10 Fr. 21 cm - 8 1/4" Ø 3.3 mm — SURTEX INSTRUMENTS LTD · Class IIa
- BR Surgical, LLC — BR SURGICAL LLC · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class II
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 | 506109272MD100VB | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Spoke Medical limited
- EUDAMED SRN
- UK-MF-000049693
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED ea0050f8-3db3-42b1-8f07-628d6a64488b 61 fields · synced Oct 8, 2026