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Spectra EchoShot Injection Needle
EUDAMEDClass IIa (EU MDR)
Ref SES22150SLModel Spectra EchoShot Injection Needle
Identity
- Trade Name
- Spectra EchoShot Injection Needle EUDAMED
- Model / Reference
- Spectra EchoShot Injection Needle EUDAMEDSES22150SL EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M661SES22150SLX EUDAMED
- Basic UDI-DI
- ++M661Needle2AMH EUDAMED
- EMDN Code
- A010399 ANAESTHESIA NEEDLES AND KIT - OTHER 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
Spectra EchoShot Injection Needle by Spectra Medical Devices, LLC — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | ++M661Needle2AMH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Spectra Medical Devices, LLC
- EUDAMED SRN
- US-MF-000008491
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 5744671e-8e5b-49b4-b9c6-6202338b5b41 61 fields · synced Jul 9, 2026