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Coapt Evaluation Kit
EUDAMEDFDA UDIClass I (EU MDR)
Ref B618Q1Model N1
by Coapt, LLC
Identity
- Trade Name
- Coapt Evaluation Kit EUDAMEDFDA UDI
- Generic Name
- Bioelectrical signal analysis software FDA UDI
- Device Name
- Complete Control System Gen2 EUDAMEDThe Coapt Evaluation Kit is a handheld clinical tool created with technology from the Coapt COMPLETE CONTROL System Gen2. It is an accessory intended to be used during the planning and alignment of myoelectric control contact locations for an upper limb prosthetic socket. FDA UDI
- Model / Reference
- N1 EUDAMEDB618Q1 EUDAMED1 FDA UDI
- Description
- The Coapt Evaluation Kit is a handheld clinical tool created with technology from the Coapt COMPLETE CONTROL System Gen2. It is an accessory intended to be used during the planning and alignment of myoelectric control contact locations for an upper limb prosthetic socket. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B618Q1 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B618N18Z EUDAMED
- FDA Product Code
- IQO FDA UDI
- EMDN Code
- Y061899,Z12100492 EUDAMED
- GMDN Term
- Bioelectrical signal analysis software FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3025 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Coapt Evaluation 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 3f232998-de8e-4255-be4b-071007ea5043 61 fields · synced Jul 30, 2026
- FDA UDI 34785ef6-f6ed-47e0-9a13-754e1540398c 33 fields · synced May 30, 2026