Identity
- Trade Name
- INTELLAGEN™ Remote Control Kit FDA UDI
- Generic Name
- Cardiac radio-frequency ablation system generator FDA UDI
- Model / Reference
- 20403 FDA UDI
Identifiers
- Catalog Number
- M004GEN100204030 FDA UDI
- Primary DI / UDI-DI
- 04260166374094 FDA UDI
- FDA Product Code
- OAD FDA UDILPB 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
Yes
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
No
FDA UDI
Category: Cardiac radio-frequency ablation system generator
INTELLAGEN™ Remote Control Kit by Stockert GmbH — Class III — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class III | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Stockert GmbH
Sources (2)
- FDA UDI d312d76b-5580-40bb-bd2e-5437aa0ee087 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026