Identity
- Trade Name
- INTELLAGEN™ RF Generator FDA UDI
- Generic Name
- Cardiac radio-frequency ablation system generator FDA UDI
- Device Name
- only commercialized as part of the kit FDA UDI
- Model / Reference
- 20404 FDA UDI
- Description
- only commercialized as part of the kit FDA UDI
Identifiers
- Catalog Number
- M004GEN100204010 FDA UDI
- Primary DI / UDI-DI
- 04260166374063 FDA UDI
- FDA Product Code
- LPB FDA UDIOAD FDA UDI
- GMDN Term
- Cardiac radio-frequency ablation system generator FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cardiac radio-frequency ablation system generator
INTELLAGEN™ RF Generator by Stockert GmbH — Class III — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac radio-frequency ablation system generator.
- nContact RF Generator — ATRICURE, INC. · Class II
- CARDIOBLATE® — MEDTRONIC, INC. · Class II
- ATAKR® II — MEDTRONIC, INC. · Class III
- Isolator Surgical Ablation System — ATRICURE, INC. · Class II
- Ampere™ — ST. JUDE MEDICAL, INC. · Class III
- DiamondTemp™ FASTR RF Generator — MEDTRONIC, INC. · Class III
- AtriCure Isolator Synergy EnCompass Clamp and Guide System — ATRICURE, INC. · Class II
- Subtle Cannula with Guide — ATRICURE, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class III | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stockert GmbH
Sources (2)
- FDA UDI 37041d24-29b8-486d-b2ae-595d664ceda7 35 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026