Identity
- Trade Name
- INTELLAGEN™ Remote Control EUDAMED
- Model / Reference
- G4 Remote EUDAMED19980 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260166373325 EUDAMED
- Basic UDI-DI
- B-04260166373325 EUDAMED
- EMDN Code
- Z12059011 CARDIAC ABLATION EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
INTELLAGEN™ Remote Control by Stockert GmbH — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04260166373325 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Stockert GmbH
- EUDAMED SRN
- DE-MF-000006981
Sources (1)
- EUDAMED 3f1c15c3-3ffb-427d-9ad0-547735f2878d 61 fields · synced May 22, 2026