Identity
- Trade Name
- Inion Cautery EUDAMEDFDA UDI
- Generic Name
- Electrocautery system generator, battery-powered FDA UDI
- Device Name
- Inion Cautery EUDAMEDCautery, Low Temperature Fine Tip FDA UDI
- Model / Reference
- HTC-0000 EUDAMED1 FDA UDI
- Description
- Cautery, Low Temperature Fine Tip FDA UDI
Identifiers
- Catalog Number
- HTC-0000 FDA UDI
- Primary DI / UDI-DI
- 06438408000003 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438408000003 EUDAMED
- FDA Product Code
- HQP FDA UDI
- EMDN Code
- K02010301 LOW TEMPERATURE BIPOLAR ELECTROCAUTERS, SINGLE USE EUDAMED
- GMDN Term
- Electrocautery system generator, battery-powered FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 886.4115 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Inion Cautery by Inion Oy — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06438408000003 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Inion Oy
- EUDAMED SRN
- FI-MF-000000646
Sources (2)
- EUDAMED 4e7c0782-c323-4db4-aa6c-d39e330c3806 61 fields · synced Jun 18, 2026
- FDA UDI fa2b3cff-8a87-48a6-94fb-b4f13bdfcc2a 35 fields · synced May 30, 2026