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3 Button Fingerswitch Wand
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref SIEC-3FHPB/NSModel SIEC-3FHPB/D
Identity
- Trade Name
- 3 Button Fingerswitch Wand EUDAMEDReusable Handpiece FDA UDI
- Generic Name
- Electrosurgical handpiece, reusable FDA UDI
- Device Name
- 3 Button Fingerswitch Wand EUDAMEDReusable Handpiece FDA UDI
- Model / Reference
- SIEC-3FHPB/D EUDAMEDSIEC-3FHPB/NS EUDAMEDFDA UDI
- Description
- Reusable Handpiece FDA UDI
Identifiers
- Catalog Number
- SIEC-3FHPB/NS FDA UDI
- Primary DI / UDI-DI
- 00810026180972 EUDAMEDFDA UDI
- Basic UDI-DI
- 0081002618SIEC-3FHPB/D8R EUDAMED
- 510(k) Number
- K212222 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- L180301 OPEN ELECTROSURGERY HANDPIECES, REUSABLE EUDAMED
- GMDN Term
- Electrosurgical handpiece, reusable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Hydrogen Peroxide FDA UDI
MR Unsafe FDA UDI
3 Button Fingerswitch Wand by Soniquence, LLC — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0081002618SIEC-3FHPB/D8R | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Soniquence, LLC
- EUDAMED SRN
- US-MF-000029810
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 6a192527-2ac5-4192-9d07-169c44f99417 61 fields · synced Jul 31, 2026
- FDA UDI 2bae2b05-48ee-40ac-af4d-1e4826226ae9 35 fields · synced May 29, 2026