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Gen2 System Kit
EUDAMEDFDA UDIClass I (EU MDR)
Ref B618P1Model N1
by Coapt, LLC
Identity
- Trade Name
- Gen2 System Kit EUDAMEDFDA UDI
- Generic Name
- Analytical non-scalp cutaneous electrode FDA UDI
- Device Name
- Complete Control System Gen2 EUDAMEDThe Gen2 System Kit is a medical device kit that contains the Coapt COMPLETE CONTROL System Gen2 (DI=B618N1) and the Coapt Dome Electrodes (DI=B618E0). FDA UDI
- Model / Reference
- N1 EUDAMEDB618P1 EUDAMED1 FDA UDI
- Description
- The Gen2 System Kit is a medical device kit that contains the Coapt COMPLETE CONTROL System Gen2 (DI=B618N1) and the Coapt Dome Electrodes (DI=B618E0). FDA UDI
Identifiers
- Primary DI / UDI-DI
- B618P1 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B618N18Z EUDAMED
- FDA Product Code
- GXY FDA UDI
- EMDN Code
- Y061899,Z12100480,Z12100492 EUDAMED
- GMDN Term
- Analytical non-scalp cutaneous electrode FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Market of Registration
- Sweden 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
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
Yes
FDA UDI
Gen2 System Kit by Coapt, LLC — 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 | ++B618N18Z | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Coapt, LLC
- EUDAMED SRN
- US-MF-000003759
- Authorised Representative
- Fillauer Europe AB SE-AR-000002627
Sources (2)
- EUDAMED ce8ec971-a709-4fe0-a855-db1d6e1538dd 61 fields · synced Jun 19, 2026
- FDA UDI ef11bb93-2a5c-4bd0-aa8d-f1fa23a8c863 34 fields · synced May 30, 2026