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Surgical Instruments (Spectra Radio Frequency (RF) Needle and Safety Scalpel)
EUDAMEDClass IIa (EU MDR)
Ref SCV220504NC
Identity
- Device Name
- Surgical Instruments (Spectra Radio Frequency (RF) Needle and Safety Scalpel) EUDAMED
- Model / Reference
- SCV220504NC EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M661SCV220504NCN EUDAMED
- Basic UDI-DI
- ++M661Inst2AWT EUDAMED
- EMDN Code
- A019099 NEEDLES FOR OTHER PROCEDURES - 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
Surgical Instruments (Spectra Radio Frequency (RF) Needle and Safety Scalpel) by Spectra Medical Devices, LLC — Class IIa — MDR — listed in EUDAMED
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 | ++M661Inst2AWT | 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 9bd0f800-29cf-423e-a684-485596aa3dbb 61 fields · synced Jun 18, 2026