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INTELLAGEN Tubing Set
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 20626Model G4-Tubing
Identity
- Trade Name
- INTELLAGEN Tubing Set EUDAMEDINTELLAGEN™ Tubing Set FDA UDI
- Generic Name
- Cardiac ablation system irrigation tubing set FDA UDI
- Device Name
- INTELLAGEN Tubing Set EUDAMEDOnly commercialized as part of the 10 PK FDA UDI
- Model / Reference
- G4-Tubing EUDAMED20626 EUDAMEDFDA UDI
- Description
- Only commercialized as part of the 10 PK FDA UDI
Identifiers
- Catalog Number
- M004GEN100206260 FDA UDI
- Primary DI / UDI-DI
- 04260166374346 EUDAMEDFDA UDI
- Basic UDI-DI
- 426016637010605100129 EUDAMED
- FDA Product Code
- OAD FDA UDI
- EMDN Code
- Z12059011 CARDIAC ABLATION EQUIPMENT EUDAMED
- GMDN Term
- Cardiac ablation system irrigation tubing set FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass III FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
INTELLAGEN Tubing Set by Stockert GmbH — Class IIa — 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 | 426016637010605100129 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Stockert GmbH
- EUDAMED SRN
- DE-MF-000006981
Sources (2)
- EUDAMED fa35854d-3ff3-4724-815e-59699e328cc7 61 fields · synced Jun 18, 2026
- FDA UDI 3ea9e5d9-0d5a-41a5-a109-adbb8cd0d5b6 36 fields · synced May 30, 2026