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INTELLAGEN™ Grounding Cable (3m)
EUDAMEDFDA UDIClass I (EU MDR)
Ref 19943Model G4 Cables
Identity
- Trade Name
- INTELLAGEN™ Grounding Cable (3m) EUDAMEDFDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- INTELLAGEN™ ECG Connection Cable (3m) EUDAMED
- Model / Reference
- G4 Cables EUDAMED19943 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- M004GEN100199430 FDA UDI
- Primary DI / UDI-DI
- 04260166373080 EUDAMEDFDA UDI
- Basic UDI-DI
- 4260166370104051001Z4 EUDAMED
- Direct Marketing DI
- 04260166373080 EUDAMED
- FDA Product Code
- OAD FDA UDILBP FDA UDI
- EMDN Code
- Z12059011 CARDIAC ABLATION EQUIPMENT EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass III FDA UDI
- Regulation Number
- 874.3450 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
INTELLAGEN™ Grounding Cable (3m) by Stockert GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4260166370104051001Z4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Stockert GmbH
- EUDAMED SRN
- DE-MF-000006981
Sources (2)
- EUDAMED 18b397c0-c602-459f-aaf9-f6e28b7af803 61 fields · synced Jun 18, 2026
- FDA UDI f7a9b239-d7d8-47a9-96af-74f5bcb4d410 35 fields · synced May 30, 2026