3-Button Fingerswitch Hp
EUDAMEDFDA UDIClass IIb (EU MDR)
by Cynosure LLC
Identity
- Trade Name
- 3-BUTTON FINGERSWITCH HP EUDAMEDFDA UDI
- Generic Name
- Electrosurgical handpiece, single-use FDA UDI
- Device Name
- 3-BUTTON FINGERSWITCH HP EUDAMEDSTERILE, 3-BUTTON FINGERSWITCH HP(10PCS) FDA UDI
- Model / Reference
- IEC-3FHPB/D EUDAMEDFDA UDI
- Description
- STERILE, 3-BUTTON FINGERSWITCH HP(10PCS) FDA UDI
Identifiers
- Catalog Number
- IEC-3FHPB/D FDA UDI
- Primary DI / UDI-DI
- 00841494105433 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00841494105433 EUDAMED
- FDA Product Code
- JOS FDA UDI
- EMDN Code
- K0201010501 OPEN ELECTROSURGERY HANDPIECES, SINGLE-USE EUDAMED
- GMDN Term
- Electrosurgical handpiece, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
3-Button Fingerswitch Hp by Cynosure, LLC — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00841494105433 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Cynosure LLC
- EUDAMED SRN
- US-MF-000010200
- Authorised Representative
- Cynosure B.V. NL-AR-000009566
Sources (2)
- EUDAMED a7cf6c8d-4406-47c9-b7c8-8a41f639d656 61 fields · synced Jun 18, 2026
- FDA UDI ce491867-3328-4e95-babb-5e449af5256d 34 fields · synced May 30, 2026