Electrosurgical Pencil, Button Switch
EUDAMEDFDA UDIClass IIb (EU MDR)
Identity
- Trade Name
- Electrosurgical Pencil, Button Switch EUDAMEDDeRoyal FDA UDI
- Generic Name
- Electrosurgical system FDA UDI
- Device Name
- Electrosurgical Pencil, Button Switch EUDAMEDFDA UDI
- Model / Reference
- 88-000223 EUDAMEDFDA UDI
- Description
- Electrosurgical Pencil, Button Switch FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00749756566995 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00749756566995 EUDAMED
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K0299 ELECTROSURGERY DEVICES, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Electrosurgical system 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
Yes
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
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Percutaneous radio-frequency ablation system generator
Electrosurgical Pencil, Button Switch by Deroyal Industries, Inc. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Percutaneous radio-frequency ablation system generator.
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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-00749756566995 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- DeRoyal Industries, Inc.
- EUDAMED SRN
- US-MF-000002102
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED b90a3630-c459-4461-a861-b862e08c635a 61 fields · synced Jun 18, 2026
- FDA UDI e47b750b-9a51-4fdf-9ff4-653fca25f96e 34 fields · synced May 30, 2026